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

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    Nitrile Examination Gloves (Model: ZMG1351)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Data-Cyte Plus P 0.8%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137342272·Reagent Red Blood Cells papainized panel used f...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180124523·5MM DIA., 36CM, INSULATED CONE TIP ELECTRODE, R...

    DATA-CYTE PLUS P 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·August 4, 2025

    DATA-CYTE PLUS P 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·August 11, 2025

    MODIFICATION TO XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM

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

    HEMOSPHERE FORESIGHT MODULE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 23, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    DEKA SMARTPERIO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 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