94 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRISTAR BONE GRAFT FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304232846·
CHARTIS CONSOLE
FDA 510(k)
FDA Class 2
·Anesthesiology
THE VITROS 5,1 FS CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
UNKNOWN FEMORAL AUGMENTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
VNGD SSK INTLK FMRL 70 LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
UNKNOWN FEMORAL AUGMENTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
UNKNOWN FEMORAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
BIOMET OFFSET TIBIAL TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
VNGD SSK PSC TIB BRG 22X71/75 5 X 22
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
UNKNOWN FEMORAL AUGMENTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 27, 2011
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
FDA Enforcement
Class II
·Terminated·Remel Inc·February 20, 2013
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 15, 2021
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DQX·July 2, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·August 12, 2024
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 25, 2022
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·May 3, 2024