15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304456235·
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
FDA 510(k)
FDA Class 2
·Hematology
ECHO B-MTRC MP FP SO 8
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 14, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 17, 2011
*
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code KDI·July 11, 2008
OSS AVL POLY TIB BUSHING SET
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 28, 2021
OSS AVL TIBIAL LOCK RING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 28, 2021
OSS TIB BLK AUG 10X63/67 UNIV
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 28, 2021
OSS POLY FEMORAL BUSHINGS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 28, 2021
OSS AVL TIB BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 28, 2021
OSS AVL YOKE 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 28, 2021
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017