9 results
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18ms
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Sources: EU EUDAMED, US FDA
DENTAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Dental
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435116667·MCD Screw 2.3 x 14 mm cannulated M1
partia...
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROFIX
FDA 510(k)
FDA Class 2
·Orthopedic
GEMSTAR PM THERAPY S
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 20, 2014
ASR XL TAP SLV ADAP 12/14+5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 7, 2012
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 30, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 10, 2021
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012