11 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989026733·ARCH KIT-ALEX TMA LOOPED-LO 16X22
PATRIOT PROTRUSIO CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
CELL-CHEX
FDA 510(k)
FDA Class 2
·Hematology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2020
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 22, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 26, 2011
FENESTRATED MARYLAND BIPOLAR INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·July 3, 2008
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012