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

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TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VEST RESTRAINT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FERRO-QUANT TM FE 59 TEST KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ENDOBON XENOGRAFT GRANULES

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LYC·February 21, 2017

ENDOBON GRANULES

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LYC·February 20, 2017

OXFORD PH3 CEMENTLESS FEM SZ L PC/HA

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·July 11, 2019

OXF UNI CMNTLS TIB SZ E LM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·July 11, 2019

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS·Product code DTB·June 10, 2014

PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010

TOTAL ASR FEM IMP SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·December 6, 2012

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 27, 2020

ENVEO PRO DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 27, 2020

EVOLUT PRO TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 27, 2020

ENVEO R DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 27, 2020

UNKN SPINE WAND AND CONTROLLER

FDA Adverse Event
Injury ·ARTHROCARE CORP.·Product code GEI·April 4, 2022

ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·April 3, 2024

SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code LMG·October 23, 2023

MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAN·October 23, 2023

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·October 23, 2023

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012