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

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    Muscle Stimulator Device (PZ-100)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Vivid ZirDisc Amman Girrbach System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500381·89x71x12mm 03HT (Translucent)

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813010440·NITI LEGACY MT CM F4 25MM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197390675·Adaptor for Fibreoptic light guide Type A...

    Femoral Head Extractor

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215037994·

    devemed

    FDA UDI
    devemed GmbH·04061644022489·Implant - Spatula, sharp # A1 especially for so...

    Easy@Home Blood Glucose Test Strip

    FDA UDI
    HMD BIOMEDICAL INC.·00810038634869·Easy@Home Blood Glucose Test Strip

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161122500380·Femoral Head Extractor

    RELIANT STENT GRAFT BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endosee System

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

    BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 7, 2017

    MSS - HUMERAL REVERSE LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 14, 2008

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·September 9, 2011

    4MM 30° C-MOUNT STYLE A ARTHROSCOPE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·July 26, 2013

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code GEI·August 21, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013