12 results
·
17ms
·
Sources: EU EUDAMED, US FDA
T3 UPTAKE KITS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113799·PS-C Insert, Size 6 x 12mm
Integra Expandable Interbody
FDA UDI
Seaspine Orthopedics Corporation·10889981049294·IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG. T...
SeaSpine Expandable Interbody
FDA UDI
Seaspine Orthopedics Corporation·10889981123512·IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG
Legacy
FDA UDI
Gc Orthodontics America Inc.·E53582261200001·LEGACY 1. MOLAR UPR LFT SZ 12
IBOND GLUMA INSIDE
FDA 510(k)
FDA Class 2
·Dental
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·November 27, 2007
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 7, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012