10 results
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21ms
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Sources: EU EUDAMED, US FDA
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
FDA 510(k)
FDA Class 1
·Dental
MICROMAX(TM) BLUNT OBTURATOR
FDA UDI
Biomet Orthopedics, LLC·00880304449985·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111097775·SIMON CURETTE #00 4.4MM 9.25"
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450208724·
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
IN-THE NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 9, 2013
FIXATION SCREW
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 10, 2010
ADVANCE(R) TOT COND FEMORAL NON-POROUS
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JWH·July 1, 2014
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