8 results · 21ms · Sources: EU EUDAMED, US FDA

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DALE ENDOTRACHEAL TUBE HOLDER

FDA 510(k)
FDA Class 1 ·Anesthesiology

Yumizen H2500

FDA 510(k)
FDA Class 2 ·Hematology

SOFTECH PLUS ETC02 CANNULA

FDA 510(k)
FDA Class 2 ·Anesthesiology

PLM A+ SPANISH 110V

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 26, 2014

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·November 15, 2012

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 2010

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017