7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REDSENSE-HOME USE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EMPIRE N BLOOD PRESSURE MANOMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
AIR DERMATOME KIT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·April 20, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012