BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Medical Diode Laser Systems (THEIA808)

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

    HORICO

    FDA UDI
    Hopf, Ringleb & Co. GmbH & Cie.·EHORW2500182·Rotary diamond instrument

    Vivid ZirDisc Wieland System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500181·98mmx18mm 03HT (Translucent)

    EasyClean Waxed Dental Floss

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063755574·EasyClean Waxed Dental Floss, unflavored, 4 met...

    Sapphire NC ULTRA Coronary Dilatation Catheter

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955982606·

    Stainless Steel Round Wire

    FDA UDI
    Ortho Arch Company Inc·D90925001813·.018 STAINLESS STEEL ROUND LENGTHS (10)

    BD NEEDLE CLIPPER SAFE-CLIP EUROPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·March 23, 2022

    TESLAOXYSAT, MODEL EFOXYSATE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VS3-IR-MMS System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197151559·JACOBSON Needle Holder,diamond dusted 250mm/...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197151542·JACOBSON Needle Holder,diamond dusted, 230mm,...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197151535·JACOBSON Needle Holder,Diamond Dust,str 190mm/...

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·June 23, 2022

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 14, 2008

    ENDO CLIP II MED/LRG 10MM PISTOL GRIP

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code FZP·September 9, 2011

    TISSUE RETRIEVAL SYSTEM

    FDA Adverse Event
    Malfunction ·ANCHOR PRODUCTS CO.·Product code GCJ·July 18, 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