BEUDAMED
    16 results · 34ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    BREATHABLE IMPERVIOUS GOWNS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ATLAS GOLD PTA DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 21, 2026

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 21, 2026

    U0605 6464602 PCA II PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION, SINGAPORE·Product code FRN·October 29, 2008

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 12, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023