9 results
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20ms
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Sources: EU EUDAMED, US FDA
NES REPROCESSED ENDOSCOPIC TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIMPLICITY WINGED QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
FDA 510(k)
FDA Class 2
·General Hospital
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC. / HUNGTINGTON·Product code HQL·May 9, 2007
ROTALINK¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·May 12, 2016
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 8, 2011
FREESTYLE FLASH
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 13, 2008
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014