BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Handheld Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 6, 2013

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    STEALTHSTATION S7 NAVIGATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 5, 2020

    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