8 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G-LIX TISSUE GRASPER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BREEZY WHEELCHAIR, MODEL 300
FDA 510(k)
FDA Class 1
·Physical Medicine
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
HUDSON ENDOTRACHEAL TUBE, HVT, 8.0
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BTR·April 10, 2013
UNKNOWN PREFILL
FDA Adverse Event
Death
·COVIDIEN·Product code NZW·April 11, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015