16 results
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44ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALIX ADVANCE Anchor with DYNACORD Suture
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271401·
ZenFlex CM
FDA UDI
Kerr Corporation·00195062145445·.15/.04/31mm ZenFlex CM NiTi FILE REFILL PACK
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304473164·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180539231·CUP CURETTE, 45° PULL, SMOOTH, SIZE 3
IND ONE STEP OCCULT BLOOD (FOB) TEST
FDA 510(k)
FDA Class 2
·Hematology
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
FDA 510(k)
FDA Class 2
·Radiology
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 18, 2014