8 results · 20ms · Sources: EU EUDAMED, US FDA

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ENDOSCOPY TABLE 1532 ENDOSTAR

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

WORKSTATIONONE BREAST IMAGING WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

Ergonomic Handle

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2015

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