8 results
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18ms
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Sources: EU EUDAMED, US FDA
MONOJECT M535 35CC SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (AJ)
FDA UDI
STERNGOLD DENTAL LLC·00841549104275·Implant retained overdentures are an establishe...
Disposable Dual Action Tissue Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TANDEM T:SLIM INSULIN DELIVERY SYS
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·May 5, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 16, 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