7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOWNLEY TOTAL KNEE (TTK)
FDA 510(k)
FDA Class 2
·Orthopedic
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
FDA 510(k)
FDA Class 1
·Radiology
VEOLAR VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·May 28, 2014
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 30, 2012
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·February 8, 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