7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAVITY ASSIST
FDA 510(k)
FDA Class 1
·General Hospital
GOLD CORE POST SOLDER
FDA 510(k)
FDA Class 2
·Dental
PC ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE GEN MODEL 105
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 30, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
MP30 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2010
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