19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FOUNTAIN Infusion Catheter and Occluding Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
Dental Glass Ceramics Blocks
FDA 510(k)
FDA Class 2
·Dental
GEBDI TRIBOS 501
FDA 510(k)
FDA Class 2
·Dental
E. CAM COMPUTER [510(K) K992731]
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SYSTEMS, INC.·Product code IYX·April 20, 2001
E.COM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 7, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·November 29, 2022
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