14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HINGE PEDIATRIC PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CATHETER, NATURAL LATEX URETHRAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
SMART PORT CT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS INCORPORATED·Product code LJT·August 4, 2010
32MM STD LFIT V40 HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·March 24, 2015
BIOMET 360 TIBIAL AUGMENT WITH BOLTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
BIOMET 360 TIBIAL AUGMENT WITH BOLTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
BIOMET 360 TIBIAL TRAY WITH TI LOCKING BAR & SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
BIOMET SPLINED KNEE STEM V2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
BIOMET 360 OFFSET ADAPTOR WITH SCREWS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
VANGUARD PS OPEN BOX FEMORAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2017
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