7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Spineology Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
FDA 510(k)
FDA Class 2
·General Hospital
ASSY, PROBE, BLADDERSCAN BVI 9400/9600
FDA Adverse Event
Malfunction
·VERATHON INCORPORATED·Product code IYO·February 15, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·January 28, 2011
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2014
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·September 11, 2009