10 results
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18ms
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Sources: EU EUDAMED, US FDA
HEMACOUNT WRIGHT GIEMSA STAIN PACK
FDA 510(k)
FDA Class 2
·Radiology
SB2 - City of Richmond
FDA UDI
Certified Safety Manufacturing, Inc.·00766588226026·SB2 - City of Richmond
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100295·Gutta-Percha, Pellets
Legacy
FDA UDI
Gc Orthodontics America Inc.·E53582260200001·LEGACY 1. MOLAR UPR LFT SZ 02
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
DRX3000
FDA 510(k)
FDA Class 2
·Physical Medicine
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
LEOPARD IMPLANT 5? LORDOTIC, 12MM
FDA Adverse Event
Malfunction
·DEPUY RAYNHAM·Product code MQP·November 7, 2012
BECKER EDMS II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code GWM·June 5, 2015
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