BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization

    FDA 510(k)
    FDA Class 2 ·Neurology

    HADGEL, 4 GRAM/SYRINGE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    GLIDER PTCA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 22, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    VIDAS CMV IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFZ·July 15, 2021

    VIDAS CMV IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFZ·July 16, 2021

    VIDAS CMV IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFZ·July 16, 2021

    VIDAS CMV IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LFZ·July 16, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·April 25, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 7, 2022

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025