BEUDAMED
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    WowGoHealth Infrared Ear & Forehead Thermometer GSH-351

    FDA UDI
    GOLDEN SMART HOME TECHNOLOGY CORP.·04719878123518·The WowGoHealth Infrared Ear & Forehead Thermom...

    WowGoHealth Blood Glucose Monitoring System GSH-BGM902

    FDA UDI
    GOLDEN SMART HOME TECHNOLOGY CORP.·04719878121019·The WowGoHealth Blood Glucose Monitoring System...

    WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301

    FDA UDI
    GOLDEN SMART HOME TECHNOLOGY CORP.·04719878123013·The WowGoHealth IR Ear Thermometer with Bluetoo...

    WowGoHealth Control Solution - GSH-BGM902 - Level 1

    FDA UDI
    GOLDEN SMART HOME TECHNOLOGY CORP.·04719878121156·The WowGoHealth Control Solution should be test...

    WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25

    FDA UDI
    GOLDEN SMART HOME TECHNOLOGY CORP.·04719878121125·The WowGoHealth Blood Glucose Test Strip is for...

    TAXUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·January 11, 2008

    HI-TORQUE WHISPER NS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·March 2, 2018

    GSH INTRAMEDULLARY NAIL 12 MM DIA 25 CM LONG

    FDA Adverse Event
    Injury ·SMITH AND NEPHEW RICHARDS, INC.·Product code HSB·July 14, 1997

    ARROW VPS RHYTHM DLX MONITOR BUNDLE

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·July 23, 2024

    SENSORMEDICS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code LSZ·September 19, 2014

    CONICAL 17 DEGREE ANGLED ABUTMENT

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 23, 2007

    BD DIFCO; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code GSH·March 2, 2021

    SPECTRA OPTIA

    FDA Adverse Event
    Injury ·TERUMO BCT·Product code GKT·April 15, 2022

    HI-TORQUE WHISPER MS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·March 2, 2018

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 18, 2023

    Antisera, All Types, Listeria Monocytogenes

    FDA classification
    FDA Class 1 ·Antisera, All Types, Listeria Monocytogenes

    GSB LLC

    FDA registration
    GSB LLC·1 product·🇺🇸 United States

    DSH MEDICAL CO., LTD.

    FDA registration
    DSH MEDICAL CO., LTD.·2 products·🇰🇷 South Korea

    SHENZHEN GSD TECH CO., LTD

    FDA registration
    SHENZHEN GSD TECH CO., LTD·5 products·🇨🇳 China

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025