BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

    FDA 510(k)
    FDA Class 2 ·Radiology

    Infinity Gateway Suite

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·October 30, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2011

    ACX DOUBLE CHAMBER TISSUE EXPANDER

    FDA Adverse Event
    Injury ·SIENTRA, INC·Product code LCJ·July 3, 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