8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
FDA 510(k)
FDA Class 2
·Physical Medicine
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209107612·
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
FDA 510(k)
FDA Class 2
·Radiology
ATB ADVANCE PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 5, 2014
PFCSIG POSTLIP INSERT SZ5 10MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code JWH·November 30, 2012
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 28, 2010
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