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

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    Fetal Doppler

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112694·BARRON CORNEAL PUNCH 9.5MM

    PG&E - 10 Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120843·PG&E - 10 Poly White

    INTRODUCER SET, MODEL ADELANTE-S SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONOREAL 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MTF·July 8, 2013

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·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