11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566386·CoRoent Ant TLIF PEEK, 15x11x34mm 8°
AGACHAMBER SPACER
FDA 510(k)
FDA Class 2
·Anesthesiology
CONSERVE TOTAL FEMORAL HEAD
FDA 510(k)
FDA Class 3
·Orthopedic
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 13, 2020
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 9, 2020
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code LFL·May 29, 2013
TOTALCARE-
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 7, 2011
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025