Device Desk

Private service · Not FDA

FDA device establishment · Morrisville, NC

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-1064858As of September 30, 2026

ANDERSEN SCIENTIFIC, INC.

Registration 1064858FEI 3008397795Morrisville, NC

Owner/operator: ANDERSEN SCIENTIFIC, INC.

  • Manufacture Device in the United States for Export Only
  • 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
85
Added, last 12 months
43

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 85

CodeDeviceClassRegulationPremarket
LZDOrthotin TMJ ReplacementJoint, Temporomandibular, ImplantAdded Mar 18, 2026Class 321 CFR 872.3940—
CACAventus Thrombectomy SystemApparatus, AutotransfusionAdded Mar 18, 2026Class 221 CFR 868.5830—
CACAventus Clot Management SystemApparatus, AutotransfusionAdded Mar 18, 2026Class 221 CFR 868.5830—
QEZAventus Thrombectomy SystemAspiration Thrombectomy CatheterAdded Mar 18, 2026Class 221 CFR 870.5150—
KRAAventus Thrombectomy SystemCatheter, Continuous FlushAdded Mar 18, 2026Class 221 CFR 870.1210—
FOZOSPREY Midline Closed IV Catheter SystemCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Mar 18, 2026Class 221 CFR 880.5200—
FOZOSPREY Closed IV Catheter SystemCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Mar 18, 2026Class 221 CFR 880.5200—
FOZOSPREY PERIPHERAL IV Catheter SystemCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Mar 18, 2026Class 221 CFR 880.5200—
DQYRadical 8F Access CatheterCatheter, PercutaneousAdded Mar 18, 2026Class 221 CFR 870.1250—
DQY. IOPS Viewpoint Simple Curve CatheterCatheter, PercutaneousAdded Mar 18, 2026Class 221 CFR 870.1250—
DQYRadical 7F Access CatheterCatheter, PercutaneousAdded Mar 18, 2026Class 221 CFR 870.1250—
DQYCatheter, PercutaneousCardiovascularClass 221 CFR 870.1250—

and 73 more on your full dossier

What changed

  • Mar 18, 2026Listing added: LZD — Orthotin TMJ Replacement
  • Mar 18, 2026Listing added: CAC — Aventus Thrombectomy System
  • Mar 18, 2026Listing added: CAC — Aventus Clot Management System
  • Mar 18, 2026Listing added: QEZ — Aventus Thrombectomy System
  • Mar 18, 2026Listing added: KRA — Aventus Thrombectomy System
  • Mar 18, 2026Listing added: FOZ — OSPREY Midline Closed IV Catheter System
  • Mar 18, 2026Listing added: FOZ — OSPREY Closed IV Catheter System
  • Mar 18, 2026Listing added: FOZ — OSPREY PERIPHERAL IV Catheter System
  • Mar 18, 2026Listing added: DQY — Radical 8F Access Catheter
  • Mar 18, 2026Listing added: DQY — . IOPS Viewpoint Simple Curve Catheter
  • Mar 18, 2026Listing added: DQY — Radical 7F Access Catheter
  • Mar 18, 2026Listing added: QJP — Radical 7F Access Catheter
  • Mar 18, 2026Listing added: QJP — Radical 8F Access Catheter
  • Mar 18, 2026Listing added: DQK — . IOPS Viewpoint Simple Curve Catheter
  • Mar 18, 2026Listing added: QOI — Orchid Safety Release Valve™
  • Mar 18, 2026Listing added: FSZ — TracLux
  • Mar 18, 2026Listing added: OWW — BioBrace(R)
  • Mar 18, 2026Listing added: OWY — BioBrace(R)
  • Mar 18, 2026Listing added: FTL — BioBrace(R)
  • Mar 18, 2026Listing added: QWJ — BioBrace(R)
  • Mar 18, 2026Listing added: FMI — StaClear Syringe
  • Mar 18, 2026Listing added: OMP — NPWT Prevent Kit
  • Mar 18, 2026Listing added: QLY — StaClear Syringe
  • Mar 18, 2026Listing added: QEW — Aventus Thrombectomy System
  • Mar 19, 2026Listing added: MBH — Optimotion™ Blue Knee System
  • Mar 19, 2026Listing added: OIY — Optimotion™ Blue Knee System
  • Mar 19, 2026Listing added: JWH — Optimotion™ Blue Knee System
  • Mar 18, 2026Listing added: GDW — Hemorrhage Occluder Pin
  • Mar 23, 2026Listing added: ETN — Evala
  • Mar 18, 2026Listing added: FMF — StaClear Syringe
  • Mar 18, 2026Listing added: KGC — PUMA-G
  • Mar 19, 2026Listing added: HTN — Tactix Vector Suture Kit
  • Mar 18, 2026Listing added: OAJ — Schaitkin Salivary
  • Mar 23, 2026Listing added: GBX — Catheter, Irrigation
  • Mar 19, 2026Listing added: LRC — Instrument, Ent Manual Surgical
  • Mar 18, 2026Listing added: LXH — Distraction screw
  • Mar 18, 2026Listing added: KGS — HEMIGARD ADHESIVE RETENTION SUTURE DEVICE
  • Mar 18, 2026Listing added: FDG — Retractor, Fiberoptic
  • Mar 18, 2026Listing added: KYZ — Colorectal Air Syringe-LP
  • Mar 18, 2026Listing added: IWJ — iWand
  • Mar 18, 2026Listing added: MKY — HEMIGARD Interlock
  • Mar 18, 2026Listing added: FTY — Tape, Measuring, Rulers And Calipers
  • Mar 18, 2026Listing added: FRO — Dressing, Wound, Drug
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.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

Already a member? Sign in

Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

More device sites in North Carolina