15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
FDA 510(k)
FDA Class 1
·Microbiology
UniTip Catheter
FDA UDI
Unisensor AG·07640172972410·
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
Anchor Bag-Alone Tissue Retrieval System by ConMed
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 19, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 26, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 21, 2012
XP-CR Tibial Tray - Interlok 79 mm Item # 195276
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET 360 TIBIAL CRUCIATE WING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
VNGD SSK 360 L FEM 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
BIOMET 360 OFFSET ADAPTOR 5MM WITH SCREWS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
BIOMET 360 TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
BIOMET SMOOTH KNEE STEMS 16X40
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
VANGUARD SERIES-A STANDARD PATELLA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 3, 2017
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019