9 results
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18ms
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Sources: EU EUDAMED, US FDA
PATIENT ISOLATOR #S-10/D-10
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
O2PAK OXYGEN GENERATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
FDA 510(k)
FDA Class 2
·Immunology
BD 3ML SYRINGE
FDA Adverse Event
Malfunction
·B-D·Product code FMF·May 15, 2014
UNKNOWN DEPUY FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LPH·November 6, 2012
4D INTEGRATED TREATMENT CONSOLE
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS·Product code IYE·August 25, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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