7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
FDA 510(k)
FDA Class 2
·Dental
DENTAURUM WIRES
FDA 510(k)
FDA Class 1
·Dental
AMCATH DISPOSABLE BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 28, 2012
PFC SIG RPF CEM FEM SZ 2.5 RT
FDA Adverse Event
Injury
·DEPUY RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·December 30, 2010
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·July 18, 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