10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTA GEO TI MODEL #2004
FDA 510(k)
FDA Class 2
·Dental
PDC IMPLANT
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MJO·April 9, 2013
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 30, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
S-ROM*SLEEVE PRX ZTT, 20F-LRG
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LPH·January 28, 2016
SROM*STM ST,36+8L NK,20X15X165
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JDI·January 28, 2016
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013