48 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
FDA 510(k)
FDA Class 2
·Cardiovascular
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270909·
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROAIRE SURGICAL INSTRUMENTS LLC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VANGUARD DCM PS TIBIBAL BEARING 14MM X 71/75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 10, 2017
POLISHED FINNED TIB TRAY 71MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRO·March 28, 2019
VNGD PS TIB BRG 10X71/75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 26, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 28, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 21, 2013
UNKNOWN VANGUARD BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 25, 2018
SERIES A PAT STD 28 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 25, 2020
BIOMET POLISHED FINNED TIBIAL TRAY 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 12, 2025
VANGUARD PS+ TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
BIOMET CC I-BEAM TRAY
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2018
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 14, 2019
VANGUARD DCM PS PLUS TIBIAL BEARING
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2018
VNGD PS TIB BRG 10X63/67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·September 19, 2019
UNKNOWN VANGUARD PATELLA
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2018
BIOMET CC I-BEAM TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 26, 2021