15 results · 20ms · Sources: EU EUDAMED, US FDA

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KLASSIC KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

ANIMEC, MODELS AM-2S-4 AND AM-2S-5

FDA 510(k)
FDA Class 2 ·General Hospital

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

TEGRESS URETHRAL IMPLANT

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON)·Product code FBK·September 17, 2014

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 25, 2011

RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

ZIMMER AIR DERMATOME

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·May 3, 2018

Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of the U.S. only).

FDA Recall
Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021