BEUDAMED
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    IGROW II HAIR GROWTH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664222482·ULTRA SHEER 20-30 MM HG THIGH W/LACE BAND CLOSE...

    Bernafon

    FDA UDI
    Bernafon AG·05711584022542·CT5 CPX, VC PS GR CANTEO 5

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970478·

    STRYKER L3 HYDROLERT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EXCELLA II SPINAL SYSTEM MODEL EC2-00

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·June 19, 2018

    REPLY

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code NVZ·May 17, 2013

    DPM 4 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY BIOMEDICAL ELECTRONICS CO. LTD.·Product code MHX·September 18, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2011

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HSB·April 4, 2017

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HSB·April 4, 2017

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026