11 results · 19ms · Sources: EU EUDAMED, 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