13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW Reverse Porous Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018722·Obturator 2.7 x 187.5mm blunt tip
SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
UNSPECIFIED PRIMARY PLUM SET
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024
SUPERCABLE ISO-ELASTIC SYSTEM
FDA Adverse Event
Injury
·KINAMED, INC.·Product code JDQ·July 21, 2015
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 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