BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VISUALINE AMPHETAMINE DIPSTRIP ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    T15 SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A·Product code LXH·April 14, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    MONARCH PLATFORM

    FDA Adverse Event
    Injury ·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022

    REVOLUTION CATHETER

    FDA Adverse Event
    Other ·VOLCANO CORPORATION·Product code DQO·October 23, 2008

    DEPUY ASR

    FDA Adverse Event
    Injury ·DEPUY·Product code KWA·August 9, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 8, 2013

    CMD 22-1105 HUMERAL IMPLANT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·February 10, 2023

    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

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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