7 results
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18ms
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Sources: EU EUDAMED, US FDA
INTRADISCAL THERAPY NEEDLE 18 GAUGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NORDICLAB PROGESTERONE RIA TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VENTURE WIRE CONTROL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 30, 2014
ION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 20, 2012
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2010
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