11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIV MEDICA CPR FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284287·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776157470·Taylor Spinal Retr 7.25" 3" Blade 1.25" Width
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776097578·Taylor Spinal Retractor
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTO*THERM 395, MODEL ME 395
FDA 510(k)
FDA Class 2
·Physical Medicine
TALENT THORACIC
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·April 11, 2013
RENAISSANCE 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 16, 2011
CC IRON/MAGNESIUM CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JIX·May 22, 2008
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·April 24, 2019
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