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

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    HONIGUM

    FDA 510(k)
    FDA Class 2 ·Dental

    Pearson

    FDA UDI
    Keystone Industries·H668D6401141·Pearson D-2 Hve White 20/50

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741182143·Catheter Placement Kit

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522111150·LWS ADAPTER, 3 LEAD, SL

    JETLITE 4000

    FDA 510(k)
    FDA Class 2 ·Dental

    NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CORTEX SCREW S.T. ?2.7X28MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·July 22, 2010

    I-STAT ACT KAOLIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code JBP·March 26, 2026

    MENTOR SILTEX CONTOUR PROFILE MODERATE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 20, 2018

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·February 15, 2008

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·September 11, 2019

    16/150 STEM EXT TRL BOW

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWT·December 5, 2023

    18/150 STEM EXT TRL BOW

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWT·December 5, 2023

    12/150 STEM EXT TRL BOW

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWT·December 5, 2023

    14/150 STEM EXT TRL BOW

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWT·December 5, 2023

    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.

    FDA Recall
    Terminated ·Gyrus Medical, Inc·Product code KNH·July 8, 2014

    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.

    FDA Enforcement
    Class II ·Terminated·Gyrus Medical, Inc·August 27, 2014

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025