FDA applicant

Ziehm International, Inc.

Annapolis, MD16 decisions1982–20010 recalls

FDA records 16 decisions for Ziehm International, Inc. (Annapolis, MD) from 1982 to 2001: 16 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FMI (Needle, Hypodermic, Single Lumen). 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 hospital panel, where it files most

How often FDA has decided Ziehm International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ziehm International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ziehm International, Inc.’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

Other applicant names beginning “Ziehm”

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

Ziehm Imaging GmbH 25 Ziehm-Orthoscan, Inc. 3

Ziehm International, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ziehm”