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

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    DeltaFil, DeltaFil Conditioner

    FDA 510(k)
    FDA Class 2 ·Dental

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506083693·Bulldog Clip appliers

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127022456·Femoral Head, 32mm, 0mm, Biolox

    TLC Uni Knee Tibial Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077051·

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    CHOICE FLOPPY GUIDEWIRE 0.14 X 182 CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MCW·March 26, 2014

    CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NARVAL CC

    FDA 510(k)
    FDA Class 2 ·Dental

    G2 EXPRESS FILTER SYSTEM- FEMORAL

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 22, 2008

    ASR ACETABULAR CUPS 52

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 9, 2013

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    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