14 results · 34ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

E-MATRIX GRAFT BONE EXTENDER

FDA 510(k)
FDA Class 2 ·Orthopedic

MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048

FDA 510(k)
FDA Class 1 ·Hematology

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·March 20, 2026

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 16, 2026

ARCHITECT TSH

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 15, 2026

SAVVY PTA DILATATION CATHETER

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code LIT·February 28, 2013

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·January 31, 2011

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014

Transvaginal Pack, part number CMP1767

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 5, 2025

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 15, 2025

ARCHITECT TSH

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 5, 2025

ARCHITECT TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 19, 2024