10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U.S. MEDICAL PS-1000 PEDIATRIC SCALE
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756366304·CMC VASCULAR PACK
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210352·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971314·
Amplatzer Trevisio Intravascular Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·November 19, 2010
ULRAFLOW HPC 1.5F
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code DYG·July 2, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 3, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021