8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 5, 2020
IN-FAST BONE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IM-9C MICROINJECTORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·April 22, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 4, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 28, 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