42 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Mesh Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
FDA 510(k)
FDA Class 2
·General Hospital
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
FDA 510(k)
FDA Class 2
·Hematology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·June 12, 2013
SERI SURGICAL SCAFFOLD (US)
FDA Adverse Event
Injury
·ALLERGAN·Product code OXF·October 9, 2014
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2023
(17-0547) ANK C/X IMPL A17/D3.5/L17
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·May 19, 2021
(17-0547) ANK C/X IMPL A17/D3.5/L17
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·April 29, 2021
(17-0547) ANK C/X IMPL A17/D3.5/L17
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·February 24, 2021
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 11, 2023