7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Insightra Freedom Ventral Hernia Repair System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOW FLOW OSV II HYDROCEPHALUS VALVE
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
3.5MM CORTEX SCREW SELF-TAPPING 30MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 23, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014