14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXTENTRAC ELITE
FDA 510(k)
FDA Class 2
·Physical Medicine
ZIMMER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HTG·February 26, 1999
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
FDA 510(k)
FDA Class 1
·General Hospital
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·December 20, 1996
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·February 6, 2025
MARKERS
FDA Adverse Event
Malfunction
·PRAXIM·Product code HAW·January 3, 2007
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013
QUANTUM SR
FDA Adverse Event
Injury
·LUMENIS, LTD.·Product code GEX·March 28, 2011
NEEDLE, BIOPSY, 8GAX4", JAMSHIDI
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code KNW·April 21, 2008
CLARION
FDA Adverse Event
Other
·ADVANCED BIONICS CORPORATION·Product code MCM·May 28, 1998
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 10, 2015
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