11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDICA II-F-ASMA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
OsteoCentric Bone Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BACKSTOP AND BACKSTOP INJECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 8, 2006
UNKNOWN STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2018
M2A-MAGNUM 42-50M TPR INSRT +3
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 13, 2018
DEPUY SYNTHES SPINE SCREW
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·May 5, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 27, 2007
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 13, 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