8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID
FDA 510(k)
FDA Class 1
·Microbiology
VALO Grand Corded
FDA 510(k)
FDA Class 2
·Dental
FILTER SET PMF 2168
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E-CAM COINCIDENCE MODE [510 (K) K970627)
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SYSTEMS, INC., NMG GROUP·Product code IYX·April 20, 2001
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·October 15, 2012
SOLETRA
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MHY·May 5, 2014
EON MINI IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 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