BEUDAMED
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    Treace Medical Concepts (TMC) Screw Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    RIGIDFIX

    FDA UDI
    Medos International Sàrl·10886705020157·RIGIDFIX CURVE Femoral Rod Soft Tissue Only 10....

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514742·

    NA

    FDA UDI
    Synthes GmbH·10886982153159·3.5MM LOCKING SCREW SELF-TAPPING 36MM

    U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS

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

    NOMOS MOTORIZED CRANE II

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLARIUS ULTRASOUND SCANNER

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

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 9, 2013

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    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