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

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    CPS Locator 3D Plus Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813034682·K-Type Files 25MM #10

    devemed

    FDA UDI
    devemed GmbH·04061644033898·Bone Spreader | 2.8 - 3.4 mm straight, graduate...

    TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM

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

    O-RING Condom

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

    BREATHING CIRCUIT SET

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code BZO·May 8, 2026

    EXT MINI CLSC 12IN RT ANGL Y EF

    FDA Adverse Event
    Injury ·APPLIED MEDICAL TECHNOLOGY, INC.·Product code KNT·September 24, 2025

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·November 25, 2008

    SENSATION

    FDA Adverse Event
    CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC·Product code DSP·September 12, 2011

    PROPLEGE CORONARY SINUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·July 29, 2013

    Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

    FDA Enforcement
    Class I ·Ongoing·TELEFLEX LLC·October 26, 2022

    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

    FDA Enforcement
    Class I ·Ongoing·TELEFLEX LLC·October 26, 2022

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023

    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

    FDA Enforcement
    Class I ·Ongoing·TELEFLEX LLC·October 26, 2022

    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

    FDA Enforcement
    Class I ·Ongoing·TELEFLEX LLC·October 26, 2022

    Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·November 19, 2025

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024