12 results
·
24ms
·
Sources: EU EUDAMED, US FDA
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
FDA 510(k)
FDA Class 2
·Radiology
IN VITRO TOBRAMYCIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNIFY QUADRA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 25, 2010
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 20, 2012
TPRLC133 MP T1 PPS SO 6X97.5MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
TPRLC 133 MP TYPE1 PPS HO 12.0 M T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
TLOC 133 MP SP T1 PPS HO 8X101
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
TPRLC 133 MP TYPE1 PPS SO 17.0 1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
TPRLC 133 T1 PPS HO 17X154MM 4MM T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020