16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOSPA IS TLIF & DLIF Cages
FDA 510(k)
FDA Class 2
·Orthopedic
SUTRALENE POLYPROPYLENE SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUINTEX CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2022
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 20, 2011
CLAVICLE PIN ASSEMBLY 2.5MM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code JDW·September 10, 2008
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2024
TRULIANT PS CEM FEM PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024