17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TENET TIBIAL FRACTURE SUPPORT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515251373·Freeman Rake Retr, 7/8" wide, 7"
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 7, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 15, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 8, 2006
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REFLOTRON CREATINE KINASE TEST TABS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code FZP·June 7, 2006
PLM A+ SPANISH 110V
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 5, 2014
UNK PERIGEE
FDA Adverse Event
Injury
·UNK·Product code OTP·February 8, 2013
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·January 11, 2011
ARTICULAR SURFACE SIZE EF 9 MM HEIGHT (5.5 MM UNDER THE CONDYLES)
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 16, 2020
ARTICULAR SURFACE 12 MM HEIGHT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 6, 2023
ARTICULAR SURFACE SIZE EF 14 MM HEIGHT "USE WITH PLATE 5
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 9, 2020
ARTICULAR SURFACE SIZE CD 12 MM HEIGHT "USE WITH PLATE 1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·April 4, 2019
UNKNOWN NEXGEN TIBIAL TRAY
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·December 3, 2019
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021