11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694832·PROXIMITY VA SELF-DRILL SCREW, 4.0 x 21mm
Insignia
FDA UDI
ALPHATEC SPINE, INC.·00190376329963·4.0mm Variable Angle, Self-Drilling Screw, Sing...
iScreen™
FDA UDI
Instant Technologies, Inc.·00817405021512·iScreen DOA Multi-Panel(Urine) 25T
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545721·SPS VA Self-Drill Screw, 4.0 x 21mm
INOMAX DS (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
NITREX NITINOL GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEATHCARE CORPORATION·Product code KDI·September 27, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·June 14, 2011
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023