10 results
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26ms
·
Sources: EU EUDAMED, US FDA
DHEA-SULFATE TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72327920413·Safco T&F bur - 12 bladed, carbide, #7204 taper...
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004472·PERC DLR SPINE WAND SURGICAL DEVICE
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460002·Perc DLR Convenience Pack Inc 17 gauge 6” Crawf...
G21 SpaceFlex Hip
FDA 510(k)
FDA Class 2
·Orthopedic
STELLAR FIDUCIAL MARKER, MODEL GFMIA
FDA 510(k)
FDA Class 2
·Radiology
MAYFIELD
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORP·Product code HBL·April 22, 2014
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·October 12, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 10, 2010
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018