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

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    SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

    FDA Enforcement
    Class II ·Ongoing·Micromed S.p.A.·June 17, 2026

    VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

    FDA Enforcement
    Class II ·Ongoing·Milestone S.R.L.·May 6, 2026

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    FDA Enforcement
    Class II ·Completed·ESAOTE S.P.A.·March 11, 2026

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System

    FDA Enforcement
    Class II ·Ongoing·Copan Italia·December 24, 2025

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

    FDA Enforcement
    Class II ·Ongoing·Copan Italia·December 24, 2025

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Copan Italia·June 18, 2025

    REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

    FDA Enforcement
    Class II ·Ongoing·Orthofix Srl·June 25, 2025

    PhenoMATRIX

    FDA Enforcement
    Class II ·Ongoing·Copan WASP·May 28, 2025

    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 2, 2025

    PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 2, 2025

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·January 1, 2025

    REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·January 23, 2013

    Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·January 23, 2013

    MyRay RXDC dental unit x-ray unit

    FDA Enforcement
    Class II ·Terminated·CEFLA DENTAL GROUP·May 29, 2013

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·June 1, 2016

    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Enforcement
    Class II ·Terminated·Villa Sistemi Medicali S.P.A.·March 15, 2017

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    FDA Enforcement
    Class II ·Terminated·HEALTH ROBOTICS S.R.L.·January 18, 2017