510(k) Report

FDA applicant

Vomed Volzer Medizintechnik GmbH & Co.

Amsterdam, Nh, NL3 decisions2002–20020 recalls

FDA records 3 decisions for Vomed Volzer Medizintechnik GmbH & Co. (Amsterdam, Nh, NL) in 2002: 3 510(k) clearances. Most are in product codes FGI (Catheter, Urethrographic, Male) and DRC (Trocar). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Vomed Volzer Medizintechnik GmbH & Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vomed Volzer Medizintechnik GmbH & Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vomed Volzer Medizintechnik GmbH & Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vomed Volzer Medizintechnik GmbH & Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FGICatheter, Urethrographic, Male1decision
  • DRCTrocar1decision
  • HIFInsufflator, Laparoscopic1decision

What has FDA decided for it lately?

  • K023019Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000Vomed Volzer Medizintechnik GmbH & Co. · 2002
  • K022257Vomed Peripheral Vascular Accessories, Models 1010 XXX-7090 XXX & 9006 XXX-9011 XXXVomed Volzer Medizintechnik GmbH & Co. · 2002
  • K022318Vomed Endoscopic and Urological AccessoriesVomed Volzer Medizintechnik GmbH & Co. · 2002

All 3 as Vomed Volzer Medizintechnik GmbH & Co. →