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

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    TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964024465·The ENDO CARRY-ON Procedure Kit contains all of...

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003802·S LEGACY Mic fcp, RH Bayo, NS DG, str 1.0 mm DD...

    Harvest Nano Zirconia

    FDA UDI
    Harvest Dental Products, LLC·D87060038181·Harvest Nano Zirconia Color Blend A1 98.5 x 18

    UTERINE TENACLUM HOOK

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

    NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 14, 2013

    PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MGB·February 7, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 26, 2008

    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 5, 2021

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024