24 results · 22ms · 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.

REDUCT® Headless Compression Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023288·270 Micron SU Thulio Performance 3m Fiber

NA

FDA UDI
Synthes GmbH·10886982142313·2.4MM CORTEX SCREW SELF-TAPPING 32MM

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·February 2, 2018

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 23, 2020

MAGLY 6.5MM CANNULATED SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

CHASE CARDIOVASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code MIH·June 27, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

NEXGEN STEMMED TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·June 28, 2013

DA+ T SERIES DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

SYNERGY

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·December 29, 2016

ROSEN AMPLATZ EXTRA STIFF WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·May 13, 2019

HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

FDA Adverse Event
Death ·HEARTWARE, INC.·Product code DSQ·August 14, 2018

HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·August 14, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·March 30, 2026

CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

ON-X AORTIC VALVE

FDA Adverse Event
Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·July 14, 2017

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021