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

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    EmbryoSlide+ ic8 dish

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

    SR IVOCRON

    FDA 510(k)
    FDA Class 2 ·Dental

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    MP70 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·August 5, 2011

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·August 14, 2014

    GYNECARE TVT-AA ABDOMINAL

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

    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·June 5, 2024

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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