BEUDAMED
    24 results · 20ms · Sources: EU EUDAMED, US FDA

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    Neuro Omega System; NeuroSmart System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464092017·OTICON JET 1 MINIRITE C091

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025562·Good Works AN Performance Pro Small 100/Box

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931253·BIT, PHILLIPS® #1 1/4 SQ

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025333·Good Works Performance Pro Small 100/Box

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383516341·"An absorbent paper points is an endodontic pap...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250601200·ceraMotion® Zr 3D Dentin CC11, 20 g / dental ce...

    Zeramic Adhesive Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    SMARTDOP 45 VASCULAR DOPPLER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD NEEDLE 18X1-1/2 RB TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·February 25, 2026

    MEDLINE

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FPA·March 3, 2026

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAILS-STER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·November 14, 2014

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 16, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPB·July 26, 2013

    MEDLINE

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FPA·March 3, 2026

    PASCAL PRECISION SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NKM·December 16, 2022

    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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