510(k) Report

FDA applicant

Angiomed U.S., Inc.

Anaheim, CA24 decisions1986–19880 recalls

FDA records 24 decisions for Angiomed U.S., Inc. (Anaheim, CA) from 1986 to 1988: 24 510(k) clearances. Most are in product codes GBO (Catheter, Nephrostomy, General & Plastic Surgery) and KOD (Catheter, Urological). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Angiomed U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Angiomed U.S., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Angiomed U.S., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GBOCatheter, Nephrostomy, General & Plastic Surgery5decisions
  • KODCatheter, Urological4decisions
  • FADStent, Ureteral2decisions
  • GDMNeedle, Aspiration And Injection, Reusable1decision
  • FFLDislodger, Stone, Basket, Ureteral, Metal1decision
  • GESBlade, Scalpel1decision

Also: KOB (1), GCD (1), KGZ (1), GBZ (1), FGE (1), DWO (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K854909Pediatric Percutaneous Nephrostomy SetsAngiomed U.S., Inc. · 19861cites it

What has FDA decided for it lately?

  • K874771Angiomed Introducing SetsAngiomed U.S., Inc. · 1988
  • K874585Angiomed Osty-Cut Bone Biopsy NeedleAngiomed U.S., Inc. · 1987
  • K864225Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentAngiomed U.S., Inc. · 1987
  • K863386Vesico Suprapubic Bladder Drainage & Exchange SetsAngiomed U.S., Inc. · 1986
  • K862805Angiomed Vac-U-Cut Biopsy NeedleAngiomed U.S., Inc. · 1986
  • K863446Angiomed High Pressure ConnectorsAngiomed U.S., Inc. · 1986
  • K854910AngioflowAngiomed U.S., Inc. · 1986
  • K854912Angiomed Guied WiresAngiomed U.S., Inc. · 1986

All 24 as Angiomed U.S., Inc. →

Other applicant names beginning “Angiomed”

FDA records each applicant name separately; these may or may not be the same firm.

Angiomed GmbH & Co. Medizintechnik KG 1