BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    InCore Subtalar System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini Twin

    FDA UDI
    Rmo, Inc.·00885797652775·ROTH MINI LP 018 HK/3 5-5 20EA

    TLC Uni Knee Tibial Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077075·

    CONCENPIECE,HIGH-SPEED HANDPIECE SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    UNI-T SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 27, 2008

    OT PING METER

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

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·July 8, 2013

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021