BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    SpyGlass Discover Balloon Dilation Catheter

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584114599·CO9 MNR, 2.4G NFM SABE DEMO CAPTO 9 GPL

    SYRINGE 20ML LL TIP CONV PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·November 6, 2023

    DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)

    FDA 510(k)
    FDA Class 2 ·Dental

    AMEDITECH IMMUTEST DRUG SCREEN PCP

    FDA 510(k)
    FDA Unclassified ·Unknown

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·October 24, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 16, 2011

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 9, 2013

    ATLAS GOLD

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