Device Desk

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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-2528981As of September 30, 2026

LYNX Medical Pennsylvania

Registration 2528981FEI 2528981ERIE, PA

Owner/operator: LYNX Medical Pennsylvania

  • Sterilize Medical Device for Another Party (Contract Sterilizer)

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
293
Added, last 12 months
293

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 293

CodeDeviceClassRegulationPremarket
PMXFlosealAbsorbable Collagen Hemostatic Agent With ThrombinAdded Dec 15, 2025Class 321 CFR 878.4490—
QBIAngelMed Guardian SystemAcute Coronary Syndrome Event DetectorAdded Dec 15, 2025Class 3——
LMFFlosealAgent, Absorbable Hemostatic, Collagen BasedAdded Dec 15, 2025Class 321 CFR 878.4490—
PNFCP StentAortic StentAdded Dec 15, 2025Class 3——
NJLNexgen Lps-Flex/Lps-Mobile Bearing KneeProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingAdded Dec 15, 2025Class 3——
OCMIsolator Synergy ClampsSurgical Cardiac Ablation Device, For Treatment Of Atrial FibrillationAdded Dec 15, 2025Class 3——
OZDImpella 2.5 Pump (Pump 250)Temporary Non-Roller Type Left Heart Support Blood PumpAdded Dec 15, 2025Class 3——
DSQ10 mm Silicon Arterial CannulaVentricular (Assist) BypassAdded Dec 15, 2025Class 3——
CACH.A.S. Kit W/O DrainApparatus, AutotransfusionAdded Dec 15, 2025Class 221 CFR 868.5830—
HRX"AnchorKnot Tissue Approximation Kit AnchorKnot Knot Pusher (2-0) and AnchorKnot Suture Cutter (2-0) AnchorKnot Suture PArthroscopeAdded Dec 15, 2025Class 221 CFR 888.1100—
OZTZ-MED IIBalloon Aortic ValvuloplastyAdded Dec 15, 2025Class 221 CFR 870.1255—
OZTNuCLEUS-X PTV CatheterBalloon Aortic ValvuloplastyAdded Dec 15, 2025Class 221 CFR 870.1255—

and 281 more on your full dossier

What changed

  • Dec 15, 2025Listing added: PMX — Floseal
  • Dec 15, 2025Listing added: QBI — AngelMed Guardian System
  • Dec 15, 2025Listing added: LMF — Floseal
  • Dec 15, 2025Listing added: PNF — CP Stent
  • Dec 15, 2025Listing added: NJL — Nexgen Lps-Flex/Lps-Mobile Bearing Knee
  • Dec 15, 2025Listing added: OCM — Isolator Synergy Clamps
  • Dec 15, 2025Listing added: OZD — Impella 2.5 Pump (Pump 250)
  • Dec 15, 2025Listing added: DSQ — 10 mm Silicon Arterial Cannula
  • Dec 15, 2025Listing added: CAC — H.A.S. Kit W/O Drain
  • Dec 15, 2025Listing added: HRX — "AnchorKnot Tissue Approximation Kit AnchorKnot Knot Pusher (2-0) and AnchorKnot Suture Cutter (2-0) AnchorKnot Suture P
  • Dec 15, 2025Listing added: OZT — Z-MED II
  • Dec 15, 2025Listing added: OZT — NuCLEUS-X PTV Catheter
  • Dec 15, 2025Listing added: GCA — Catheter, Biliary, Surgical - Ponsky Cholangiography System - Taper Tip; Ponsky Guidewire Cholangiography System-Round T
  • Dec 15, 2025Listing added: FCG — Biopsy Needle - Articulator Injection Needle
  • Dec 15, 2025Listing added: NUN — Optecure Dental
  • Dec 15, 2025Listing added: DSA — RFP-100A Connector Cable (reusable)
  • Dec 15, 2025Listing added: LKF — FS Device
  • Dec 15, 2025Listing added: PDU — PowerWire Radiofrequency GuideWire Kit
  • Dec 15, 2025Listing added: LIT — Impact Catheter
  • Dec 15, 2025Listing added: LIT — PTV - Pulmonary
  • Dec 15, 2025Listing added: LIT — Tyshak Mini
  • Dec 15, 2025Listing added: LIT — Atrioseptostomy
  • Dec 15, 2025Listing added: LIT — Z-MED
  • Dec 15, 2025Listing added: LIT — CATHETER, PERCUTANEOUS
  • Dec 15, 2025Listing added: LIT — Z-MED II, 4-18, 20, 22, 23, 25, 26, 28, 30 and 2-6 cm lengths
  • Dec 15, 2025Listing added: LIT — Z-MED, 3, 11, 13, 17, 19, 23, 24, 26 mm
  • Dec 15, 2025Listing added: NVM — BIB catheter
  • Dec 15, 2025Listing added: NVM — Catheter, angioplasty, peripheral, transluminal, dual-balloon
  • Dec 15, 2025Listing added: DWF — 24 Fr Venous Cannula
  • Dec 15, 2025Listing added: DWF — 17 Fr Arterial Cannula
  • Dec 15, 2025Listing added: DWF — Transseptal Cannula EF72
  • Dec 15, 2025Listing added: DWF — Transseptal Cannula EF
  • Dec 15, 2025Listing added: DWF — Bypass Vein Canula
  • Dec 15, 2025Listing added: DWF — 15 Fr Arterial Cannula
  • Dec 15, 2025Listing added: DRF — "EPstar Fixed Electrophysiology Catheter EPstar Electrophysiology Cable "
  • Dec 15, 2025Listing added: DRF — "EPstar Fixed Electrophysiology Catheter with Lumen EPstar Electrophysiology Cable"
  • Dec 15, 2025Listing added: MSD — Symetrex Longterm Hemodialysis Catheter
  • Dec 15, 2025Listing added: MJN — Catheter, intravascular occluding, temporary
  • Dec 15, 2025Listing added: MJN — PTS
  • Dec 15, 2025Listing added: MJN — COBRA-OS, Kit Reference Number F01K1
  • Dec 15, 2025Listing added: MJN — Atrioseptostomy
  • Dec 15, 2025Listing added: MJN — PTS-X
  • Dec 15, 2025Listing added: DQO — Atrioseptostomy
  • Dec 15, 2025Listing added: DQO — MMTA Angio Catheter
  • Dec 15, 2025Listing added: DQO — MMTA Angio
  • Dec 15, 2025Listing added: DQY — Mullins -X
  • Dec 15, 2025Listing added: DQY — Atrioseptostomy
  • Dec 15, 2025Listing added: DQY — Mullins - X
  • Dec 15, 2025Listing added: DQY — Tyshak-X
  • Dec 15, 2025Listing added: DQY — Z-MED, 3, 11, 13, 17, 19, 23, 24, 26 mm
  • Dec 15, 2025Listing added: DQY — Z-MED
  • Dec 15, 2025Listing added: DQY — NuCLEUS - X
  • Dec 15, 2025Listing added: DQY — Tyshak Mini
  • Dec 15, 2025Listing added: DQY — Tyshak NuCLEUS
  • Dec 15, 2025Listing added: DQY — CATHETER, PERCUTANEOUS
  • Dec 15, 2025Listing added: DQY — Mini Ghost
  • Dec 15, 2025Listing added: DQY — Z-MED II
  • Dec 15, 2025Listing added: DQY — TorFlex Transseptal Guiding Sheath
  • Dec 15, 2025Listing added: DXF — Nykanen Radiofrequency Wire
  • Dec 15, 2025Listing added: DXF — Atrioseptostomy, Braided version
  • Dec 15, 2025Listing added: DXF — SupraCross RF Wire
  • Dec 15, 2025Listing added: DXF — NRG Transseptal Needle
  • Dec 15, 2025Listing added: DXF — Atrioseptostomy
  • Dec 15, 2025Listing added: DXF — Z-6 Atrioseptostomy Catheter
  • Apr 30, 2026Listing added: KOB — MiniSPC Button
  • Dec 15, 2025Listing added: DXC — Bypass Vein Clamp
  • Dec 15, 2025Listing added: FDF — Colonoscope And Accessories, Flexible/Rigid - Oracle EUS Balloon
  • Dec 15, 2025Listing added: FDF — Colonoscope And Accessories, Flexible/Rigid - BioGuard Air/Water Suction Valve 2-Piece Kit
  • Dec 15, 2025Listing added: HEW — FS Device
  • Dec 15, 2025Listing added: KNQ — Impact Catheter
  • Dec 15, 2025Listing added: KNQ — EZDilate Balloon Dilator Fixed Wire
  • Dec 15, 2025Listing added: DRE — ExpanSure Large Access Transseptal Dilator
  • Dec 15, 2025Listing added: DRE — Dilator Set 14 Fr to 22 Fr
  • Dec 15, 2025Listing added: DRE — TorFlex Transseptal Guiding Sheath
  • Dec 15, 2025Listing added: FGO — Dislodger, Stone, Flexible - Falcon Grasping Device; Talon Grasping Device
  • Dec 15, 2025Listing added: GZL — Electrode
  • Dec 15, 2025Listing added: GZL — Electrodes
  • Dec 15, 2025Listing added: GEI — Nykanen Radiofrequency Wire
  • Dec 15, 2025Listing added: GEI — SAF-T-VAC
  • Dec 15, 2025Listing added: ODC — Colonoscope And Accessories, Flexible/Rigid - BioGuard Air/Water Suction Valve 2-Piece Kit
  • Dec 15, 2025Listing added: FDX — Endoscopic Cytology Brush - Infinity ERCP Sampling Device
  • Dec 15, 2025Listing added: FDX — Endoscopic Cytology Brush - Cytology Brus
  • Dec 15, 2025Listing added: OCZ — Raptor Grasping Device
  • Dec 15, 2025Listing added: OCX — Endoscopic Irrigation/Suction System - Torrent Irrigation Scope Connector - PENTAX; Torrent Irrigation Tubing
  • Dec 15, 2025Listing added: OCX — Endoscopic Irrigation/Suction System
  • Dec 15, 2025Listing added: OCX — Endoscopic Irrigation/Suction System - Reveal Distal Attachment Cap
  • Dec 15, 2025Listing added: OCX — Endoscopic Irrigation/Suction System - Velocity Biopsy Valve
  • Dec 15, 2025Listing added: ODD — Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula - Bioshield
  • Dec 15, 2025Listing added: FPB — Transducer Protectors
  • Dec 15, 2025Listing added: KGE — Forceps, Biopsy, Electric - Biopsy Forceps - Hot; Biopsy Forceps - Hot - Enteroscope
  • Dec 15, 2025Listing added: OQG — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: OQG — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: OQG — Dual Mobility Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: OQG — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: OQG — iNSitu Total Hip System
  • Dec 15, 2025Listing added: OQI — iNSitu Total Hip System
  • Dec 15, 2025Listing added: OQI — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: OQI — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: OQI — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: OQH — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: OQH — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: OQH — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: KNW — Biopsy Forceps - Enteroscope
  • Dec 15, 2025Listing added: DYB — VersaCross Transseptal Sheath
  • Dec 15, 2025Listing added: DYB — VersaCross Steerable Sheath
  • Dec 15, 2025Listing added: DYB — SupraCross Steerable Sheath
  • Dec 15, 2025Listing added: DYB — DYB Introducer Catheter
  • Dec 15, 2025Listing added: DYB — TorFlex Transseptal Guiding Sheath
  • Dec 15, 2025Listing added: EXD — MiniACE
  • Dec 15, 2025Listing added: FTD — Single Tip Light
  • Dec 15, 2025Listing added: FTD — Dual Tip Light
  • Apr 30, 2026Listing added: GCJ — RHAPSO Suture Passer
  • Dec 15, 2025Listing added: GCJ — Roth Net - Foreign Body Enteroscope
  • Dec 15, 2025Listing added: GCJ — RD180 Device
  • Dec 15, 2025Listing added: GCJ — Guyuron Endoscopic Access Device
  • Dec 15, 2025Listing added: GCJ — Laparoscope, General & Plastic Surgery - Ponsky Endo-Sock
  • Dec 15, 2025Listing added: FQH — Pulsavac tip with Shield
  • Dec 15, 2025Listing added: FFK — Cyberwand Dual Probe Lithotripter
  • Dec 15, 2025Listing added: FFK — Cyberwand Sterile Probe Set
  • Dec 15, 2025Listing added: FFK — Cyberwand Dual Action Ultrasonic Lithotripsy System
  • Dec 15, 2025Listing added: FFK — UreTron Sterile Probe
  • Dec 15, 2025Listing added: FFK — Ure Tron Multipore Lithotripter System
  • Dec 15, 2025Listing added: FFK — Cybersonics Cyberwand Hollow Semi-Flexible Ureteral Probe
  • Dec 15, 2025Listing added: FFK — Cyberwand Lithotripter with Sterile Probes
  • Dec 15, 2025Listing added: FEO — Shock Pulse-SE Lithotripsy System CyberWand II
  • Dec 15, 2025Listing added: KPK — Bypass Mrker
  • Dec 15, 2025Listing added: FTL — Polydioxanone Surgical Scaffold
  • Dec 15, 2025Listing added: HAW — NDI Passive Spheres
  • Dec 15, 2025Listing added: HAW — Stereotaxic Instrument
  • Dec 15, 2025Listing added: HAW — Disposable Reflective Marker Spheres
  • Dec 15, 2025Listing added: OLO — Disposable Reflective Marker Spheres
  • Dec 15, 2025Listing added: OLO — Orthopedic stereotaxic instrument
  • Dec 15, 2025Listing added: DTZ — TandemLung Oxygenator
  • Dec 15, 2025Listing added: GEX — Powered Laser Surgical Instrument
  • Dec 15, 2025Listing added: HSN — PROLONG TIBIAL INSERT
  • Dec 15, 2025Listing added: JDC — Zimmer Nexel Total Elbow
  • Dec 15, 2025Listing added: JDC — NEXEL ELBOW
  • Dec 15, 2025Listing added: KWZ — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: KWZ — Longevity IT Highly CrossLinked Polyethylene Constrained Liners
  • Dec 15, 2025Listing added: KWZ — Trabecular Metal Acetabular Revision System Cemented Contrained Liner
  • Dec 15, 2025Listing added: KWZ — Trilogy Longevity Constrained Liner
  • Dec 15, 2025Listing added: KWY — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: KWY — Dual Mobility Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: LZO — Longevity IT Highly CrossLinked Polyethylene Elevated Liners
  • Dec 15, 2025Listing added: LZO — Longevity IT Highly Crosslinked Polyethyene Liners
  • Dec 15, 2025Listing added: LZO — Dual Mobility Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: LZO — Continuum
  • Dec 15, 2025Listing added: LZO — Continuum and Triology Integrated Taper (IT)
  • Dec 15, 2025Listing added: LZO — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: LZO — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: LZO — Zimmer Continuum Acetabular System
  • Dec 15, 2025Listing added: LZO — Continuum and Trilogy Integrated Taper Acetabular Systems
  • Dec 15, 2025Listing added: LZO — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: LZO — iNSitu Total Hip System
  • Dec 15, 2025Listing added: JDI — Continuum and Trilogy Integrated Taper Acetabular Systems
  • Dec 15, 2025Listing added: JDI — Trabecular Metal Revision Shell Liners
  • Dec 15, 2025Listing added: JDI — Continuum
  • Dec 15, 2025Listing added: JDI — Continuum and Triology Integrated Taper (IT)
  • Dec 15, 2025Listing added: JDI — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: JDI — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: JDI — Longevity IT Highly CrossLinked Polyethylene Elevated Liners
  • Dec 15, 2025Listing added: JDI — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: JDI — Longevity IT Highly Crosslinked Polyethyene Liners
  • Dec 15, 2025Listing added: JDI — Zimmer Continuum Acetabular System
  • Dec 15, 2025Listing added: LPH — Longevity IT Highly Crosslinked Polyethyene Liners
  • Dec 15, 2025Listing added: LPH — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
  • Dec 15, 2025Listing added: LPH — Trilogy Acetabular System Longevity Crosslinked Polyethulene
  • Dec 15, 2025Listing added: LPH — Longevity IT Highly CrossLinked Polyethylene Elevated Liners
  • Dec 15, 2025Listing added: LPH — Zimmer Continuum Acetabular System
  • Dec 15, 2025Listing added: LPH — Dual Mobility Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: LPH — iNSitu Total Hip System
  • Dec 15, 2025Listing added: LPH — Continuum and Triology Integrated Taper (IT)
  • Dec 15, 2025Listing added: LPH — Continuum and Trilogy Integrated Taper Acetabular Systems
  • Dec 15, 2025Listing added: LPH — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: LPH — Continuum
  • Dec 15, 2025Listing added: LPH — G7 Acetabular System Longevity and Vivacit-E Liners
  • Dec 15, 2025Listing added: LWJ — Zimmer, Inc. Hip Joint Prostheses MR Labeling 1
  • Dec 15, 2025Listing added: KRO — Zimmer Knee Joint Replacement Prostheses MR Labeling
  • Apr 30, 2026Listing added: HSX — Persona Partial Knee
  • Dec 15, 2025Listing added: HSX — Persona Partial Knee System
  • Dec 15, 2025Listing added: KRR — Zimmer Knee Joint Replacement Prostheses MR Labeling
  • Dec 15, 2025Listing added: MBH — Zimmer Persona Personalized Knee System
  • Dec 15, 2025Listing added: MBH — Zimmer Persona TM Personailized Knee System
  • Dec 15, 2025Listing added: MBH — NesgenComplete Knee Solution
  • Dec 15, 2025Listing added: MBH — Zimmer Persona The Personalized Knee System
  • Dec 15, 2025Listing added: MBH — Zimmer Knee Joint Replacement Prostheses MR Labeling
  • Dec 15, 2025Listing added: MBH — Persona Revision Knee System
  • Dec 15, 2025Listing added: MBH — Vanguard Complete Knee System
  • Dec 15, 2025Listing added: OIY — Persona Revision Knee System
  • Dec 15, 2025Listing added: OIY — Zimmer Persona TM Personailized Knee System
  • Dec 15, 2025Listing added: OIY — Vanguard Complete Knee System
  • Dec 15, 2025Listing added: OIY — Zimmer Persona Personalized Knee System
  • Dec 15, 2025Listing added: OIY — Zimmer Persona The Personalized Knee System
  • Dec 15, 2025Listing added: JWH — Zimmer Persona The Personalized Knee System
  • Dec 15, 2025Listing added: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  • Dec 15, 2025Listing added: JWH — Vanguard Complete Knee System
  • Dec 15, 2025Listing added: JWH — Zimmer Persona Personalized Knee System
  • Dec 15, 2025Listing added: JWH — Persona Revision Knee System
  • Dec 15, 2025Listing added: JWH — Zimmer Knee Joint Replacement Prostheses MR Labeling
  • Dec 15, 2025Listing added: JWH — Zimmer Persona TM Personailized Knee System
  • Dec 15, 2025Listing added: JWH — NesgenComplete Knee Solution
  • Dec 15, 2025Listing added: JWH — Nexgen Prolong All-Poly Patella
  • Dec 15, 2025Listing added: JWH — Prolong Highly Crosslinked Polyethylene Cruciate Retaining Articular Surface Components
  • Dec 15, 2025Listing added: HSD — Anatomical Shoulder TM Combined System
  • Apr 30, 2026Listing added: HSD — Zimmer Biomet Reverse Shoulder Prosthesis
  • Dec 15, 2025Listing added: HSD — Identity Shoulder System
  • Dec 15, 2025Listing added: KWT — Anatomical Shoulder TM Combined System
  • Dec 15, 2025Listing added: KWT — Identity Shoulder System
  • Apr 30, 2026Listing added: KWT — Zimmer Biomet Reverse Shoulder Prosthesis
  • Dec 15, 2025Listing added: KWT — Comprehensive Reverse Shoulder System
  • Dec 15, 2025Listing added: PAO — Comprehensive Reverse Shoulder System
  • Dec 15, 2025Listing added: KWS — Comprehensive Reverse Shoulder System
  • Dec 15, 2025Listing added: KWS — Identity Shoulder System
  • Dec 15, 2025Listing added: KWS — Anatomical Shoulder TM Combined System
  • Apr 30, 2026Listing added: KWS — Zimmer Biomet Reverse Shoulder Prosthesis
  • Apr 30, 2026Listing added: MBF — Zimmer Biomet Reverse Shoulder Prosthesis
  • Dec 15, 2025Listing added: MBF — Identity Shoulder System
  • Dec 15, 2025Listing added: OMZ — COEfficient
  • Dec 15, 2025Listing added: OMZ — Atrioseptostomy
  • Dec 15, 2025Listing added: FEQ — Pump, Air, Non-Manual, For Endoscope - AquaShield System - PENTAX; AquaShield System CO2
  • Dec 15, 2025Listing added: FEQ — AquaShield System CO2
  • Dec 15, 2025Listing added: FEQ — Pump, Air, Non-Manual, For Endoscope - AQUASHIELD
  • Dec 15, 2025Listing added: KFM — Quick Set-up Kit
  • Dec 15, 2025Listing added: KFM — TandemHeart Pump
  • Dec 15, 2025Listing added: FRN — Infusion Pump
  • Dec 15, 2025Listing added: HWC — Resorbable Interference Screw (Screw, Fixation, Bone)
  • Dec 15, 2025Listing added: FPA — MED-RX Transfer Set
  • Dec 15, 2025Listing added: FPA — MED-RX Extension Sets
  • Dec 15, 2025Listing added: FPA — MED-RX Patient Delivery Set
  • Dec 15, 2025Listing added: FPA — MED-RX Extension Set w/ T-Connector
  • Apr 30, 2026Listing added: PHX — Zimmer Biomet Reverse Shoulder Prosthesis
  • Dec 15, 2025Listing added: PHX — Identity Shoulder System
  • Dec 15, 2025Listing added: PHX — Comprehensive Reverse Shoulder System
  • Dec 15, 2025Listing added: FDI — Snare, Flexible - ISnare System - Hexagonal Snare; ISnare System - Oval Snare
  • Dec 15, 2025Listing added: FDI — Snare, Flexible - Lariat Snare
  • Dec 15, 2025Listing added: FDI — Snare, Flexible - Histolock
  • Dec 15, 2025Listing added: FDI — Roth Net - Foreign Body Enteroscope
  • Dec 15, 2025Listing added: FDI — Snare, Flexible
  • Dec 15, 2025Listing added: FGE — EZDilate Balloon Dilator Fixed Wire
  • Dec 15, 2025Listing added: OCL — Coolrail Linear Pen Model
  • Dec 15, 2025Listing added: OCL — Isolator Transpolar Pen System
  • Dec 15, 2025Listing added: OCL — Bipolar System
  • Dec 15, 2025Listing added: OCL — Isolator Multifunctional Linear Pen
  • Dec 15, 2025Listing added: GAM — RD QUICK LOAD SUTURE 0 Polyester
  • Dec 15, 2025Listing added: GAS — RD180 Device
  • Dec 15, 2025Listing added: GAS — RD QUICK LOAD SUTURE 0 Polyester
  • Dec 15, 2025Listing added: GAS — RAM COR-Suture Quickload
  • Dec 15, 2025Listing added: GAT — RD DEVICE
  • Dec 15, 2025Listing added: GAT — AnchorKnot Suture
  • Apr 30, 2026Listing added: GAT — RHAPSO Suture Passer
  • Dec 15, 2025Listing added: GAW — RD180 Device
  • Dec 15, 2025Listing added: GAW — RAM COR-Suture Quickload
  • Dec 15, 2025Listing added: GAW — RD QUICK LOAD SUTURE 0 Polyester
  • Dec 15, 2025Listing added: NEW — RD QUICK LOAD SUTURE 0 Polyester
  • Dec 15, 2025Listing added: NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule - ADVANCE CAPSULE DELIVERY DEVICE
  • Dec 15, 2025Listing added: ITX — Colonoscope And Accessories, Flexible/Rigid - Oracle EUS Balloon
  • Dec 15, 2025Listing added: FPD — NG Tubes
  • Dec 15, 2025Listing added: FPD — MED-RX Pediatric Feeding Tubes and Accessories
  • Apr 30, 2026Listing added: KGC — RHAPSO Suture Passer
  • Dec 15, 2025Listing added: KGC — Decompression Tube
  • Dec 15, 2025Listing added: KGC — ATLAS U-Stitch
  • Dec 15, 2025Listing added: KNT — Tubes, Gastrointestinal (And Accessories) - Non-Balloon Replacement PEG
  • Apr 30, 2026Listing added: KNT — MiniSPC Button
  • Dec 15, 2025Listing added: KNT — Traditional G-Jet
  • Dec 15, 2025Listing added: KNT — Balloon Stoma Measuring Device
  • Dec 15, 2025Listing added: KNT — Mini Balloon Button
  • Dec 15, 2025Listing added: KNT — Mini One Feeding Sets
  • Dec 15, 2025Listing added: KNT — MiniACE
  • Dec 15, 2025Listing added: KNT — AMT Introducer (Guidewire Compatible)
  • Dec 15, 2025Listing added: KNT — G- Jet
  • Dec 15, 2025Listing added: KNT — Mini One Balloon Button
  • Dec 15, 2025Listing added: KNT — Balloon G-Tube
  • Dec 15, 2025Listing added: KNT — AMT Capsule Dome Gastrostomy Tube
  • Dec 15, 2025Listing added: KNT — Pull PEG System
  • Dec 15, 2025Listing added: KNT — Basic Dilator Kit
  • Dec 15, 2025Listing added: KNT — micro G-Jet
  • Dec 15, 2025Listing added: KNT — MED-RX Oral/Enteral Syringe
  • Dec 15, 2025Listing added: KNT — Capsule Non-Balloon Button
  • Dec 15, 2025Listing added: KNT — NutraGlide Nasal Feeding Tube
  • Dec 15, 2025Listing added: KNT — Guidewire Accessory
  • Dec 15, 2025Listing added: BSB — Quantum Thermal Tubing Sets
  • Dec 15, 2025Listing added: LGZ — Infusion Pump
  • Dec 15, 2025Listing added: LGZ — Quantum Thermal Tubing Sets
  • Dec 15, 2025Listing added: DQX — ProTrack Microcatheter
  • Dec 15, 2025Listing added: GCY — Bifurcated Drain Extension
  • Dec 15, 2025Listing added: GDI — Atricure Dissector
  • Dec 15, 2025Listing added: HCF — RD180 Device
  • Dec 15, 2025Listing added: HCF — RD DEVICE
  • Dec 15, 2025Listing added: GAD — Wilson Scrotal Pack
  • Apr 30, 2026Listing added: FTY — AMT Balloon Measuring Device
  • Dec 15, 2025Listing added: KCY — Hoses, Hose Assembly, Single Hose w/CPC Conncectors
  • Dec 15, 2025Listing added: NPV — Pulmonary valve prosthesis percutaneously delivered
  • Dec 15, 2025Listing added: PBL — Impella Pump 350, DVRS
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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