11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
C-REACTIVE PROTEIN TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223320·Cervical Rasp 6x16x13
TOWERLOX PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LITE MINERAL OIL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code JDQ·May 29, 2015
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·May 20, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 7, 2012
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·August 26, 2010
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 2, 2015
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·November 6, 2013
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018