81 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
FDA 510(k)
FDA Class 2
·Neurology
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0120020·Driver Shaft, Final Tighten
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120120·Screwdriver, Polyaxial, Standard
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120020·T-Handle, T25, Screw Height Adjuster
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369685·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab
MAGNUM
FDA 510(k)
FDA Class 2
·Physical Medicine
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2014
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 5, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 5, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025