9 results
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17ms
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Sources: EU EUDAMED, US FDA
ROTO REST KINETIC TREATMENT TABLE PEDIA
FDA 510(k)
FDA Class 2
·Physical Medicine
Alpine SL
FDA UDI
Rmo, Inc.·00885797695284·ROTH ALPINE SL 022 HK/345 5-5 20 EA
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788224020·Cervical Trial + DS 7x12x12 Flat
DISPOSABLE PRESSURE MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
LPP (LOW PROFILE PORT)
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
SIG MOD TIB TRAY CEM COCR 4
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·November 7, 2012
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36 CM - 15 MM ACTIV
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GEI·August 17, 2007
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