12 results
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18ms
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Sources: EU EUDAMED, US FDA
SILICONE RUBBER-BI NASOPHARYNGEAL AIR
FDA 510(k)
FDA Class 1
·Anesthesiology
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72327920183·Safco T&F bur - 12 bladed, carbide, #7902 needl...
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW
Continuum® Trilogy® IT Allofit® IT Acetabular Systems
FDA UDI
Zimmer, Inc.·00889024152892·
OMNIPRO INCLINE
FDA 510(k)
FDA Class 2
·Radiology
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012
ACCU-CHEK ® ADVANTAGE PLUS TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·August 10, 2010
2021898-2018-00378
FDA Adverse Event
Injury
·July 30, 2018
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code GWM·July 30, 2018
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