8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LTD POLYAXIAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
TWINTRODE ELC 134 ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·April 11, 2013
RADIAL JAW 4 BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·April 19, 2011
GUNTHER TULIP VENA CAVA FILTER SET - JUGULAR APPROACH
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·June 17, 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