9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
FDA 510(k)
FDA Class 1
·Physical Medicine
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268216331·CUSTOM SURGICAL KIT VEIN PACK
ECAT VISION PET SCANNER, MODELS 3000 & 5000
FDA 510(k)
FDA Class 2
·Radiology
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
FDA 510(k)
FDA Class 1
·Microbiology
KIT RSV 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 15, 2021
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·May 20, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012
ZERO TIP NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·August 31, 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