22 results
·
30ms
·
Sources: EU EUDAMED, US FDA
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
PRESTIGE® LP Cervical Disc System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994714824·HANDLE 6973000 INSERTER HANDLE US
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994301895·COMPRESSOR 7973000 LG
artegral HD
FDA UDI
Merz Dental GmbH·D7091973000·posteriors; shade A1; size XL; upper jaw
Matira
FDA UDI
Kalitec Direct LLC·B073K0730000·Plate Bender, Universal
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
FDA 510(k)
FDA Class 2
·Radiology
LUMAPROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Zimmer, Inc.·00889024065611·
BIOMET MODULAR TIBIAL LOCKING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 27, 2018
BIOMET CC I-BEAM TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 27, 2018
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code MJO·August 25, 2025
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MJO·April 16, 2025
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
PROXIMATE** LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 21, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·January 20, 2011
GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·August 1, 2014
E1 VANGUARD TIBIAL BEARING CR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 27, 2018
VANGUARD CR FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 27, 2018
BIOMET SERIES THIN PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 27, 2018
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 12, 2018