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