9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KCI NPWT GAUZE DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDICAL VISORS MV100
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO GELBFISH VASCULAR DILATORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376668611·12mm CORE, NANOTEC BAN 12 x 35 mm 7°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376669243·12mm CORE, NANOTEC KBN 12 x 35 mm 7°
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 9, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
FDA Enforcement
Class I
·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013