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

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    CORE-CLIP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CD-Chex CD34

    FDA UDI
    STRECK, INC.·00844509000495·A positive procedural control for enumerating C...

    BARRICADE EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDICAL AIR COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KNW·March 12, 2026

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·August 16, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS·Product code OYC·October 13, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code LWE·October 8, 2025

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    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