19 results · 20ms · Sources: EU EUDAMED, 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