Device Desk

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FDA device establishment · Fort Lauderdale, FL

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3043226252As of September 30, 2026

ZAPALIGN LLC

Registration 3043226252FEI 3043226252Fort Lauderdale, FL

Owner/operator: Zapalign LLC

  • Manufacture Device in the United States for Export Only
  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
320
Added, last 12 months
320

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 320

CodeDeviceClassRegulationPremarket
MKJAutomated External Defibrillators (Non-Wearable)CardiovascularAdded Mar 17, 2026Class 321 CFR 870.5310K003548
MKJElectrode, electrocardiograph, multi-functionAutomated External Defibrillators (Non-Wearable)Added Jun 29, 2026Class 321 CFR 870.5310K980857
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, UrologyAdded Mar 17, 2026Class 221 CFR 876.5820K823707
EBZActivator, Ultraviolet, For PolymerizationDentalAdded Mar 31, 2026Class 221 CFR 872.6070K191865
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATIONActivator, Ultraviolet, For PolymerizationAdded Aug 7, 2026Class 221 CFR 872.6070K032465
KLEAGENT, TOOTH BONDING, RESINAgent, Tooth Bonding, ResinAdded Sep 16, 2026Class 221 CFR 872.3200K192961
KLEAgent, Tooth Bonding, ResinDentalAdded Apr 16, 2026Class 221 CFR 872.3200K962812
KLEEBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESINAgent, Tooth Bonding, ResinAdded Jun 25, 2026Class 221 CFR 872.3200K150933
KLEAgent, Tooth Bonding, ResinDentalAdded Mar 25, 2026Class 221 CFR 872.3200K920424
KLEAgent, Tooth Bonding, ResinDentalAdded Mar 19, 2026Class 221 CFR 872.3200K110302
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiologyAdded Apr 16, 2026Class 221 CFR 868.1400K122075
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASEAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Jun 25, 2026Class 221 CFR 868.1400K151421

and 308 more on your full dossier

What changed

  • Mar 17, 2026Listing added: MKJ — Automated External Defibrillators (Non-Wearable) (K003548)
  • Jun 29, 2026Listing added: MKJ — Electrode, electrocardiograph, multi-function (K980857)
  • Mar 17, 2026Listing added: KOC — Accessories, Blood Circuit, Hemodialysis (K823707)
  • Mar 31, 2026Listing added: EBZ — Activator, Ultraviolet, For Polymerization (K191865)
  • Aug 7, 2026Listing added: EBZ — ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION (K032465)
  • Sep 16, 2026Listing added: KLE — AGENT, TOOTH BONDING, RESIN (K192961)
  • Apr 16, 2026Listing added: KLE — Agent, Tooth Bonding, Resin (K962812)
  • Jun 25, 2026Listing added: KLE — EBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESIN (K150933)
  • Mar 25, 2026Listing added: KLE — Agent, Tooth Bonding, Resin (K920424)
  • Mar 19, 2026Listing added: KLE — Agent, Tooth Bonding, Resin (K110302)
  • Apr 16, 2026Listing added: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (K122075)
  • Jun 25, 2026Listing added: CCK — ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (K151421)
  • Feb 23, 2026Listing added: CAZ — Anesthesia Conduction Kit (K925902)
  • Aug 19, 2026Listing added: CAZ — NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (K012584)
  • Mar 17, 2026Listing added: FYD — Apparatus, Exhaust, Surgical (K012991)
  • Apr 16, 2026Listing added: FYD — Apparatus, Exhaust, Surgical (K230547)
  • Apr 16, 2026Listing added: FYD — Apparatus, Exhaust, Surgical (K983333)
  • Mar 3, 2026Listing added: HRX — Arthroscope (K033573)
  • Apr 10, 2026Listing added: HRX — Arthroscope (K960787)
  • Aug 19, 2026Listing added: BYE — Attachment, breathing, positive end expiratory pressure (K090710)
  • Mar 3, 2026Listing added: DXQ — Blood Pressure Cuff (K043286)
  • Feb 24, 2026Listing added: EOQ — Bronchoscope (Flexible Or Rigid) (K042140)
  • Mar 3, 2026Listing added: BTG — Brush, Biopsy, Bronchoscope (Non-Rigid) (K820771)
  • Apr 16, 2026Listing added: LKF — Cannula, Manipulator/Injector, Uterine (K093556)
  • Sep 16, 2026Listing added: LKF — Cannula, manipulator/injector, uterine (K071907)
  • Mar 17, 2026Listing added: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (K032843)
  • Feb 24, 2026Listing added: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (K990236)
  • Apr 16, 2026Listing added: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (K183399)
  • Feb 23, 2026Listing added: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (K151698)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K962065)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K911842)
  • Feb 8, 2026Listing added: EMA — Cement, Dental (K973201)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K094007)
  • Mar 25, 2026Listing added: EMA — Cement, Dental (K002452)
  • Mar 25, 2026Listing added: EMA — Cement, Dental (K073395)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K191122)
  • Aug 7, 2026Listing added: EMA — CEMENT, DENTAL (K040906)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K153174)
  • Mar 25, 2026Listing added: EMA — Cement, Dental (K933139)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K100756)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K925027)
  • Mar 19, 2026Listing added: EMA — Cement, Dental (K110508)
  • Mar 25, 2026Listing added: EMA — Cement, Dental (K062292)
  • Apr 16, 2026Listing added: ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (K173477)
  • Mar 3, 2026Listing added: MMK — Container, Sharps (K150333)
  • Mar 3, 2026Listing added: FLL — Continuous Measurement Thermometer (K863646)
  • Mar 17, 2026Listing added: FLL — Continuous Measurement Thermometer (K101747)
  • Mar 19, 2026Listing added: EBG — Crown And Bridge, Temporary, Resin (K875133)
  • Mar 3, 2026Listing added: HHK — Curette, Suction, Endometrial (And Accessories) (K030935)
  • Mar 17, 2026Listing added: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System (K041005)
  • Mar 3, 2026Listing added: LSL — Dna-Reagents, Neisseria (K081825)
  • Mar 17, 2026Listing added: KKX — Drape, Surgical, Antimicrobial (K862801)
  • Feb 23, 2026Listing added: KKX — Drape, Surgical, Antimicrobial (K031287)
  • Apr 16, 2026Listing added: KKX — Drape, Surgical, Antimicrobial (K050322)
  • Jun 10, 2026Listing added: DPS — SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph (K141582)
  • Mar 17, 2026Listing added: GXY — Electrode, Cutaneous (K032278)
  • Mar 17, 2026Listing added: DRX — Electrode, Electrocardiograph (K030509)
  • Feb 24, 2026Listing added: DRX — Electrode, Electrocardiograph (K091856)
  • Mar 3, 2026Listing added: DRX — Electrode, Electrocardiograph (K901555)
  • Feb 23, 2026Listing added: DRX — Electrode, Electrocardiograph (K000690)
  • Jun 29, 2026Listing added: MLN — Electrode, electrocardiograph, multi-function (K980857)
  • Mar 3, 2026Listing added: JOS — Electrode, Electrosurgical (K954633)
  • Mar 3, 2026Listing added: JOS — Electrode, Electrosurgical (K120322)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K033003)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K001159)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K791137)
  • Feb 24, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K944681)
  • Feb 24, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K023492)
  • Feb 24, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K031085)
  • Mar 17, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K942215)
  • Feb 8, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K033232)
  • Apr 16, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K230547)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K052104)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K954633)
  • Apr 16, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K954056)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K800597)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K120322)
  • Mar 17, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K061878)
  • Mar 3, 2026Listing added: GEI — Electrosurgical, Cutting & Coagulation & Accessories (K081634)
  • Feb 24, 2026Listing added: ODG — Endoscopic Ultrasound System, Gastroenterology-Urology (K042140)
  • Apr 10, 2026Listing added: FPB — Filter, Infusion Line (K242339)
  • Feb 24, 2026Listing added: FDS — Gastroscope And Accessories, Flexible/Rigid (K042140)
  • Feb 24, 2026Listing added: FYA — Gown, Surgical (K781682)
  • Sep 15, 2026Listing added: KMW — HANDPIECE, ROTARY BONE CUTTING (K080939)
  • Aug 19, 2026Listing added: BTT — HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (K161719)
  • Mar 17, 2026Listing added: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) (K894000)
  • Mar 17, 2026Listing added: HIH — Hysteroscope (And Accessories) (K890328)
  • Apr 16, 2026Listing added: FRC — Indicator, Biological Sterilization Process (K173584)
  • Apr 16, 2026Listing added: FRC — Indicator, Biological Sterilization Process (K173519)
  • Feb 24, 2026Listing added: FRC — Indicator, Biological Sterilization Process (K152060)
  • Apr 16, 2026Listing added: JOJ — Indicator, Physical/Chemical Sterilization Process (K220942)
  • Mar 17, 2026Listing added: GCJ — Laparoscope, General & Plastic Surgery (K924011)
  • Mar 3, 2026Listing added: GCJ — Laparoscope, General & Plastic Surgery (K033573)
  • Apr 16, 2026Listing added: GCJ — Laparoscope, General & Plastic Surgery (K950170)
  • Mar 3, 2026Listing added: GCJ — Laparoscope, General & Plastic Surgery (K934916)
  • Mar 3, 2026Listing added: DOF — Lead, Atomic Absorption (K052549)
  • Mar 17, 2026Listing added: FHN — Ligator, Hemorrhoidal
  • Mar 31, 2026Listing added: NTK — Light Transmission Caries Detector (K191865)
  • Mar 25, 2026Listing added: EJK — Liner, Cavity, Calcium Hydroxide (K073395)
  • Feb 24, 2026Listing added: FXX — Mask, Surgical (K143287)
  • Apr 16, 2026Listing added: FXX — Mask, Surgical (K082258)
  • Mar 17, 2026Listing added: FXX — Mask, Surgical (K911334)
  • Feb 24, 2026Listing added: FXX — Mask, Surgical (K111402)
  • Apr 16, 2026Listing added: ELW — Material, Impression (K043131)
  • Jun 25, 2026Listing added: ELW — MATERIAL, IMPRESSION (K130647)
  • Aug 8, 2026Listing added: ELW — MATERIAL, IMPRESSION (K981091)
  • Mar 25, 2026Listing added: ELW — Material, Impression (K992897)
  • Apr 16, 2026Listing added: ELW — Material, Impression (K113406)
  • Mar 19, 2026Listing added: ELW — Material, Impression (K032001)
  • Mar 25, 2026Listing added: ELW — Material, Impression (K800485)
  • Mar 19, 2026Listing added: ELW — Material, Impression (K131404)
  • Mar 19, 2026Listing added: ELW — Material, Impression (K960547)
  • Jun 25, 2026Listing added: EBF — EBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESIN (K150933)
  • May 22, 2026Listing added: EBF — Material, Tooth Shade, Resin (K260783)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K994251)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K141081)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K100235)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K221695)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K183476)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K120453)
  • Mar 19, 2026Listing added: EBF — Material, Tooth Shade, Resin (K163207)
  • Feb 23, 2026Listing added: BSP — Needle, Conduction, Anesthetic (W/Wo Introducer) (K081446)
  • Aug 19, 2026Listing added: BSP — NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (K100241)
  • Aug 19, 2026Listing added: BSP — NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (K091758)
  • Aug 19, 2026Listing added: BSP — NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (K012584)
  • Aug 19, 2026Listing added: BSP — NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (K961151)
  • Mar 3, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K021475)
  • Feb 24, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K982541)
  • Mar 3, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K071785)
  • Mar 17, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K862610)
  • Mar 3, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K011786)
  • Feb 23, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K895705)
  • Mar 17, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K934591)
  • Feb 23, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K951254)
  • Feb 23, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K923127)
  • Aug 7, 2026Listing added: EBI — RESIN, DENTURE, RELINING, REPAIRING, REBASING (K892452)
  • Apr 16, 2026Listing added: ELC — Scaler, Ultrasonic (K132322)
  • Feb 8, 2026Listing added: ELC — Scaler, Ultrasonic (K970123)
  • May 22, 2026Listing added: EBC — Sealant, Pit And Fissure, And Conditioner (K260783)
  • Mar 25, 2026Listing added: EBC — Sealant, Pit And Fissure, And Conditioner (K073395)
  • Mar 19, 2026Listing added: EBC — Sealant, Pit And Fissure, And Conditioner (K221695)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K180739)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K242339)
  • Feb 24, 2026Listing added: FPA — Set, Administration, Intravascular (K013621)
  • Apr 16, 2026Listing added: FPA — Set, Administration, Intravascular (K081361)
  • Mar 3, 2026Listing added: FPA — Set, Administration, Intravascular (K811885)
  • Mar 17, 2026Listing added: FPA — Set, Administration, Intravascular (K072542)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K925126)
  • Mar 3, 2026Listing added: FPA — Set, Administration, Intravascular (K061285)
  • Mar 17, 2026Listing added: FPA — Set, Administration, Intravascular (K082806)
  • Mar 17, 2026Listing added: FPA — Set, Administration, Intravascular (K032150)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K142011)
  • Feb 23, 2026Listing added: FPA — Set, Administration, Intravascular (K030573)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K112893)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K921899)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K153158)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K123868)
  • Apr 10, 2026Listing added: FPA — Set, Administration, Intravascular (K961225)
  • Mar 17, 2026Listing added: FPA — Set, Administration, Intravascular (K053106)
  • Sep 10, 2026Listing added: FPA — Set, administration, intravascular (K050600)
  • Apr 16, 2026Listing added: FPA — Set, Administration, Intravascular (K173477)
  • Mar 17, 2026Listing added: LHI — Set, I.V. Fluid Transfer (K090634)
  • Apr 16, 2026Listing added: LHI — Set, I.V. Fluid Transfer (K081361)
  • Apr 16, 2026Listing added: LHI — Set, I.V. Fluid Transfer (K173477)
  • Mar 17, 2026Listing added: FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (K923302)
  • Apr 28, 2026Listing added: FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (K101145)
  • Mar 17, 2026Listing added: JOW — Sleeve, Limb, Compressible (K091700)
  • Feb 20, 2026Listing added: HIB — Speculum, Vaginal, Nonmetal (K070964)
  • Mar 3, 2026Listing added: HIB — Speculum, Vaginal, Nonmetal (K120743)
  • Jun 10, 2026Listing added: BZG — SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph (K141582)
  • Mar 17, 2026Listing added: BWF — Spirometer, Therapeutic (Incentive) (K002768)
  • Apr 16, 2026Listing added: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (K941327)
  • Feb 23, 2026Listing added: DQD — Stethoscope, Electronic (K050159)
  • Jun 18, 2026Listing added: DWL — Stocking, medical support (to prevent pooling of blood in legs)
  • Mar 17, 2026Listing added: DWL — Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) (K902497)
  • Mar 17, 2026Listing added: GAL — Suture, Absorbable, Natural (K930825)
  • Jul 6, 2026Listing added: GAM — Suture, absorbable, synthetic, polyglycolic acid (K141558)
  • Apr 16, 2026Listing added: GAP — Suture, Nonabsorbable, Silk (K930826)
  • Mar 17, 2026Listing added: GAP — Suture, Nonabsorbable, Silk (K930825)
  • Mar 17, 2026Listing added: GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (K930825)
  • Mar 17, 2026Listing added: GAT — Suture, Nonabsorbable, Synthetic, Polyethylene (K930825)
  • Mar 17, 2026Listing added: GAW — Suture, Nonabsorbable, Synthetic, Polypropylene (K930825)
  • Apr 16, 2026Listing added: GAW — Suture, Nonabsorbable, Synthetic, Polypropylene (K131224)
  • May 22, 2026Listing added: NEW — Suture, Surgical, Absorbable, Polydioxanone (K132268)
  • Feb 20, 2026Listing added: MEG — Syringe, Antistick (K992734)
  • Feb 24, 2026Listing added: MEG — Syringe, Antistick (K011103)
  • Mar 3, 2026Listing added: FMF — Syringe, Piston (K021475)
  • Feb 23, 2026Listing added: FMF — Syringe, Piston (K924072)
  • Mar 17, 2026Listing added: FMF — Syringe, Piston (K162081)
  • Apr 10, 2026Listing added: FMF — Syringe, Piston (K872743)
  • Feb 24, 2026Listing added: FMF — Syringe, Piston (K011103)
  • Mar 17, 2026Listing added: FMF — Syringe, Piston (K110771)
  • Mar 3, 2026Listing added: HHI — System, Abortion, Vacuum (K030935)
  • Mar 17, 2026Listing added: GKR — System, Hemoglobin, Automated (K032203)
  • Apr 10, 2026Listing added: LJH — System, Irrigation, Urological (K960787)
  • Mar 17, 2026Listing added: DXN — System, Measurement, Blood-Pressure, Non-Invasive (K152770)
  • Mar 17, 2026Listing added: DWJ — System, Thermal Regulating (K060865)
  • Feb 24, 2026Listing added: MUH — System, X-Ray, Extraoral Source, Digital (K081903)
  • May 2, 2026Listing added: MPN — Tissue adhesive for the topical approximation of skin (K101276)
  • Apr 16, 2026Listing added: MPN — Tissue Adhesive For The Topical Approximation Of Skin (K152476)
  • Apr 16, 2026Listing added: DXO — Transducer, Pressure, Catheter Tip (K141495)
  • Feb 24, 2026Listing added: ITX — Transducer, Ultrasonic, Diagnostic (K042140)
  • Aug 6, 2026Listing added: FCM — Tray, catheterization, sterile urethral, with or without catheter (kit) (K030664)
  • Mar 17, 2026Listing added: JOH — Tube Tracheostomy And Tube Cuff (K914088)
  • Feb 24, 2026Listing added: JOH — Tube Tracheostomy And Tube Cuff (K923878)
  • Feb 24, 2026Listing added: JOH — Tube Tracheostomy And Tube Cuff (K944178)
  • Apr 16, 2026Listing added: JOH — Tube Tracheostomy And Tube Cuff (K083641)
  • Jun 18, 2026Listing added: JOH — Tube tracheostomy and tube cuff (K150844)
  • Aug 19, 2026Listing added: FPD — TUBE, NASOGASTRIC (K082238)
  • Aug 19, 2026Listing added: BSS — TUBE, NASOGASTRIC (K082238)
  • Aug 19, 2026Listing added: BTR — Tube, tracheal (w/wo connector) (K080339)
  • Mar 3, 2026Listing added: BTR — Tube, Tracheal (W/Wo Connector) (K822082)
  • Aug 19, 2026Listing added: BTO — Tube, tracheostomy (w/wo connector) (K030381)
  • Aug 19, 2026Listing added: BTO — Tube, tracheostomy (w/wo connector) (K912469)
  • Aug 19, 2026Listing added: BTO — Tube, tracheostomy (w/wo connector) (K811447)
  • Mar 3, 2026Listing added: ETD — Tube, Tympanostomy (K932166)
  • Mar 17, 2026Listing added: KNT — Tubes, Gastrointestinal (And Accessories) (K853253)
  • Aug 6, 2026Listing added: KNT — Tubes, gastrointestinal (and accessories) (K992719)
  • Mar 3, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K021475)
  • Mar 17, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K032150)
  • Feb 23, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K991088)
  • Mar 3, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K093972)
  • Feb 23, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K945952)
  • Feb 20, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K242320)
  • Feb 24, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K081229)
  • Feb 23, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K030573)
  • Mar 3, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K922445)
  • Feb 23, 2026Listing added: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (K923090)
  • Mar 25, 2026Listing added: LBH — Varnish, Cavity (K073395)
  • May 22, 2026Listing added: LBH — Varnish, Cavity (K260783)
  • Mar 3, 2026Listing added: FRG — Wrap, Sterilization (K143053)
  • Aug 19, 2026Listing added: BSF — ABSORBER, CARBON-DIOXIDE
  • Mar 3, 2026Listing added: NBH — Accessories, Arthroscopic
  • Feb 24, 2026Listing added: MNL — Accessories, Cleaning Brushes, For Endoscope
  • Apr 16, 2026Listing added: NDP — Accessories, Implant, Dental, Endosseous
  • Mar 3, 2026Listing added: LYU — Accessory, Surgical Apparel
  • Apr 16, 2026Listing added: CAE — Airway, Oropharyngeal, Anesthesiology
  • Feb 24, 2026Listing added: GNX — Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
  • Feb 24, 2026Listing added: GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
  • Mar 17, 2026Listing added: KQO — Automated Urinalysis System
  • Feb 20, 2026Listing added: FQM — Bandage, Elastic
  • Jun 18, 2026Listing added: KMF — Bandage, liquid (K955103)
  • Mar 17, 2026Listing added: MQM — Bilirubin (Total And Unbound) In The Neonate Test System (K010052)
  • Feb 8, 2026Listing added: GFA — Blade, Saw, General & Plastic Surgery, Surgical
  • Feb 23, 2026Listing added: GES — Blade, Scalpel
  • Jun 8, 2026Listing added: GFF — BUR, SURGICAL, GENERAL & PLASTIC SURGERY
  • Mar 3, 2026Listing added: GEA — Cannula, Surgical, General & Plastic Surgery
  • Aug 19, 2026Listing added: BSY — CATHETERS, SUCTION, TRACHEOBRONCHIAL
  • Feb 20, 2026Listing added: BYD — Condenser, Heat And Moisture (Artificial Nose)
  • Feb 23, 2026Listing added: KYW — Container, Liquid Medication, Graduated
  • Mar 17, 2026Listing added: FMH — Container, Specimen, Sterile
  • Mar 19, 2026Listing added: ELZ — Crown, Preformed
  • Apr 16, 2026Listing added: EMS — Curette, Periodontic
  • Mar 3, 2026Listing added: FZS — Curette, Surgical, General Use
  • Apr 16, 2026Listing added: EIE — Dam, Rubber
  • Feb 24, 2026Listing added: KMK — Device, Intravascular Catheter Securement
  • Mar 19, 2026Listing added: EHJ — Disk, Abrasive
  • Mar 3, 2026Listing added: KYX — Dispenser, Liquid Medication (K792227)
  • Mar 3, 2026Listing added: MLA — Dna Probe, Yeast
  • Apr 16, 2026Listing added: NAE — Dressing, Wound, Hydrogel Without Drug And/Or Biologic
  • Mar 3, 2026Listing added: NAC — Dressing, Wound, Hydrophilic
  • Feb 20, 2026Listing added: NAD — Dressing, Wound, Occlusive
  • Jun 18, 2026Listing added: MDA — Elastomer, silicone, for scar management
  • Apr 16, 2026Listing added: EMJ — Elevator, Surgical, Dental
  • Mar 17, 2026Listing added: MNK — Endoscopic Bite Block
  • Mar 3, 2026Listing added: LJC — Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) (K946276)
  • Mar 3, 2026Listing added: GXB — Esthesiometer
  • Mar 3, 2026Listing added: GEN — Forceps, General & Plastic Surgery
  • Apr 16, 2026Listing added: EJG — Forceps, Rubber Dam Clamp
  • Apr 16, 2026Listing added: EMG — Forceps, Tooth Extractor, Surgical
  • Apr 16, 2026Listing added: KBN — Gag, Mouth
  • Apr 16, 2026Listing added: EYQ — Garment, Protective, For Incontinence
  • Apr 16, 2026Listing added: NAB — Gauze / Sponge,Nonresorbable For External Use
  • Aug 27, 2026Listing added: EFB — Handpiece, air-powered, dental (K143704)
  • Sep 15, 2026Listing added: EGS — Handpiece, contra- and right-angle attachment, dental (K011061)
  • Mar 3, 2026Listing added: LYR — Helicobacter Pylori (K991747)
  • Mar 31, 2026Listing added: EGZ — Holder, Film, X-Ray
  • Mar 17, 2026Listing added: FHQ — Holder, Needle, Gastroenterologic
  • Mar 19, 2026Listing added: DZN — Instruments, Dental Hand
  • Aug 19, 2026Listing added: BSJ — MASK, GAS, ANESTHETIC
  • Apr 16, 2026Listing added: EAX — Mirror, Mouth
  • Mar 3, 2026Listing added: CCQ — Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
  • Mar 17, 2026Listing added: GAA — Needle, Aspiration And Injection, Disposable (K790061)
  • Feb 24, 2026Listing added: GAA — Needle, Aspiration And Injection, Disposable
  • Mar 3, 2026Listing added: JYR — Nipper, Malleus
  • Mar 3, 2026Listing added: OEA — Non-Surgical Gown
  • Apr 16, 2026Listing added: IQK — Orthosis, Cervical
  • Apr 16, 2026Listing added: IPT — Orthosis, Thoracic
  • Mar 17, 2026Listing added: ERA — Otoscope
  • Mar 3, 2026Listing added: EHL — Point, Abrasive
  • Aug 27, 2026Listing added: LZA — Polymer patient examination glove (K972306)
  • Mar 19, 2026Listing added: ELR — Post, Root Canal
  • Jun 18, 2026Listing added: EXE — Protector, ostomy
  • Apr 16, 2026Listing added: FMP — Protector, Skin Pressure
  • Mar 3, 2026Listing added: LRY — Punch, Surgical
  • Feb 24, 2026Listing added: LWK — Razor, Surgical
  • Apr 16, 2026Listing added: EIG — Retractor, All Types
  • Apr 16, 2026Listing added: EMN — Scaler, Periodontic
  • Mar 3, 2026Listing added: GDX — Scalpel, One-Piece
  • Mar 3, 2026Listing added: LRW — Scissors, General, Surgical
  • Feb 24, 2026Listing added: ILI — Sling, Arm
  • Mar 17, 2026Listing added: NOC — Splint, Extremity, Non-Inflatable, External, Non-Sterile
  • Aug 19, 2026Listing added: BTK — STRAP, HEAD, GAS MASK
  • Aug 19, 2026Listing added: BSR — STYLET, TRACHEAL TUBE
  • Apr 16, 2026Listing added: CCX — Support, Patient Position
  • Mar 3, 2026Listing added: KGO — Surgeon'S Gloves (K011721)
  • Mar 3, 2026Listing added: KGO — Surgeon'S Gloves (K121897)
  • Mar 17, 2026Listing added: JTW — System, Transport, Aerobic (K790366)
  • Mar 25, 2026Listing added: KGX — Tape And Bandage, Adhesive (K813265)
  • Feb 20, 2026Listing added: KGX — Tape And Bandage, Adhesive
  • Apr 16, 2026Listing added: FSM — Tray, Surgical, Instrument
  • Feb 24, 2026Listing added: GIO — Tube, Collection, Capillary Blood
  • Mar 3, 2026Listing added: NKC — Tubing/Tubing With Filter, Insufflation, Laparoscopic
  • Sep 15, 2026Listing added: EIA — Unit, operative dental (K012505)
  • Mar 25, 2026Listing added: EJQ — Wheel, Polishing Agent
  • May 2, 2026Listing added: EMB — ZINC OXIDE EUGENOL
  • Mar 25, 2026Listing added: MVL — Cord, Retraction (K093721)
  • May 2, 2026Listing added: FRO — Dressing, Wound, Drug (K100029)
  • Feb 20, 2026Listing added: FRO — Dressing, Wound, Drug (K071354)
  • Feb 20, 2026Listing added: FRO — Dressing, Wound, Drug (K130040)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

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