13 results
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18ms
·
Sources: EU EUDAMED, US FDA
EMIT-ST SERUM PHENCYCLIDINE ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
Custom Healthcare Systems Inc.
FDA UDI
Manus Medical, LLC·00811870030888·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756017336·BUCKS TRACTION
Coonrad/Morrey Total Elbow
FDA UDI
Zimmer, Inc.·00889024405202·
Life Instruments
FDA UDI
Life Instrument Corporation·M930781060100·Jakes Forcep
FANELLI BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SENTINELLA 102
FDA 510(k)
FDA Class 1
·Radiology
PYRAMESH® IMPLANT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 6, 2014
SECURA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·August 23, 2010
PYRAMESH IMPLANT SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016
Ingenia 3.0T CX-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: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021