29 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150319·Endo Carry-on Procedure Kit Includes Intercept ...
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033161906·
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00860001797985·OXY-1 US Power Cord 3M Qty 1
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033161883·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033161890·
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·00813502012354·OXY-1 Condensate Tray Qty 5
Abiomed Breethe OXY-1 System
FDA UDI
Breethe, Inc.·10860001797920·Condensation Tray Pouch Assembly
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033161876·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033161869·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100030·Tap, 4.5mm Cann, Chuckable
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100030·Caddie, 4 Level Plates
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 13, 2025
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 11, 2025
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 31, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 19, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 11, 2007