21 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SNAZZY2
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009949·Zirlux 16+ White 100X12
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294727·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294758·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294710·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294741·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294703·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294734·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294697·
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025
SPARROWHAWK DISPOSABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYOPLAN SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 18, 2025
QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 20, 2025
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022