9 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSULATED THERMOELASTOMER MITT
FDA 510(k)
FDA Class 1
·Physical Medicine
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435061288·MCD Screw.2.3 x 22 mm M1
non lo...
Legacy
FDA UDI
Gc Orthodontics America Inc.·E53582362200001·LEGACY 1. MOLAR LWR LFT SZ 22
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUSON
FDA 510(k)
FDA Class 2
·Radiology
FT BIPOLAR RESECTION CORD STORZ
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·February 28, 2014
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·November 2, 2012
REMSTAR BIPAP AUTO M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 27, 2010
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