12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
IMMO PHASE FSH RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222270·Cervical Slap Hammer
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M7526822227·CUSTOM SURGICAL KIT - VEIN
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822227200·Ortho-Cast M-Series, buccal tube, double rectan...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822227100·Ortho-Cast M-Series, buccal tube, double rectan...
ANASTIM II TRANSCUTANEOUS ELECTRICAL
FDA 510(k)
FDA Class 2
·Neurology
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 11, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014
HARMONIC SCALPEL GENERATOR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·December 3, 2007
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
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