10 results
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26ms
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Sources: EU EUDAMED, US FDA
LUTEINIZING HORMONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Terumo Cardiovascular Systems
FDA UDI
Med Michigan Holdings, LLC·00817278010804·Retrograde Cardioplegia Cannula, Manual Inflate...
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048304·3 hole flanges
ENDOSCOPE REPROCESSOR OER-MINI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
800 SERIES EASYNEB NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
PLMA DVC V11.51 1 R
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 31, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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