20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
FDA 510(k)
FDA Class 1
·Physical Medicine
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950013364·HANDLE FOR ACE MINI BLADES 5" 13CM
LITHODIAMOND ULTRA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MYOTRON
FDA 510(k)
FDA Class 2
·Neurology
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 8, 2025
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
UNKNOWN
FDA Adverse Event
Injury
·UNKNOWN·Product code FTR·October 4, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·December 7, 2012
VNGD POST FEM AUG 70X10 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
VNGD DIST FEM AUG 70X15 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
VANGUARD AUGMENT BOLT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
POROUS FINN STEM 89MMX15.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
BIOMET TIB BLOCK 10MM 71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
VNGD DIST FEM AUG 70X15 RL/LM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
POROUS FINN STEM 152MMX17.5MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 16, 2015
VANGUARD PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2019
VANGUARD INTERLOK FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2019
BIOMET INTERLOK STEM TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2019
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