7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NXSTAGE CARTRIDGE EXPRESS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVOFINE (30G) (NEEDLE) NA
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·October 5, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 8, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012