BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    HALO

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVERSTICK

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOEYE HD II

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 31, 2025

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 3, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·August 10, 2011

    GYNECARE TVT OBURATOR SYSTEM

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

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023

    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