24 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150652·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 200mm
"2.4MM" SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036056469·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
EZ-IO
FDA 510(k)
FDA Class 2
·General Hospital
CC TIBIAL INSERT SZ 4, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
TRANSVENE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWS·February 9, 2013
TRIAGE PROFILER SOB 25 TEST KIT
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code MMI·January 3, 2011
MAXI MOVE
FDA Adverse Event
Injury
·ARJO MED AB LTD.·Product code FSA·July 2, 2014
CC TIBIAL INSERT SZ 3, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
CC TIBIAL INSERT SZ 2, 9MM
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·October 25, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 30, 2025
WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·November 28, 2018
CC TIBIAL INSERT SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
TRAPEZOID TIBIAL TRAY SZ 5F/5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 25, 2024
TRAPEZOID TIBIAL TRAY SZ 5F/5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 30, 2025
CC FEMORAL SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 27, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 9, 2024