8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IS-ANTI-PR3 IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376301792·In-Situ Sagittal Bender Tip, Left, 4.0mm
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAMMODIAGNOST VU
FDA 510(k)
FDA Class 2
·Radiology
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 4, 2011
3MM FLUTED MATCHSTICK
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024