13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LARGE VOLUME 5 MICRON CONICAL FILTER
FDA 510(k)
FDA Class 2
·General Hospital
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...
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP
Continuum® Trilogy® IT Allofit® IT Acetabular Systems
FDA UDI
Zimmer, Inc.·00889024152922·
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
FDA 510(k)
FDA Unclassified
·Unknown
NCB Polyaxial Locking Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN
FDA Adverse Event
Injury
·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·November 1, 2021
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 22, 2015
VALIANT NAVION
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·February 1, 2022
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