18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
FDA 510(k)
FDA Class 2
·Hematology
ADVIA Centaur® MYO MCM
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414180014·Myoglobin Master Curve Material Set - CENTAUR -...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089452521·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033283·Coupling Treatment Tube for Metal Needles (26)
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENS CARE, MODEL XL-Y3
FDA 510(k)
FDA Class 2
·Neurology
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·January 4, 2019
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·January 4, 2019
UNK LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 10, 2025
IMPACTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·May 14, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NFA·August 13, 2008
UNKNOWN BIOLOX TAPER +3 NECK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·November 5, 2025
UNK BIOMET STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 6, 2025
UNK BIOMET SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 6, 2025
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·July 17, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025