10 results
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22ms
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Sources: EU EUDAMED, US FDA
MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TEMPERATURE SENSING FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIMPLIFLOS DENTAL FLOSSER
FDA 510(k)
FDA Class 1
·Dental
SYMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·November 9, 2010
C230 COMPRESSOR
FDA Adverse Event
Injury
·EKOM SPOL. SR. O·Product code BTI·December 27, 2012
Catheter Pack, part number AMS4399(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020