13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ESI MODEL MS-103
FDA 510(k)
FDA Class 2
·Neurology
Bioseal Inc.
FDA UDI
BIOSEAL·00630094188515·Filter Paper Grade 2
MOELLERS DECARBOXYLASE, LYSINE
FDA 510(k)
FDA Class 1
·Microbiology
ATI DISPOSABLE BIOLOGICAL TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 1, 2015
9X25MM 400LB SHRT CPS SPDL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 20, 2026
CUST 10MM RS AVL YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 20, 2026
10MM RS AVL TIB BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 20, 2026
INGEVITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·July 1, 2015
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 22, 2010
AXERA 2 ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS INC.·Product code DYB·December 19, 2012
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020