BEUDAMED
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    A Chemical Vapor Sterilization Multivariable Chemical Indicator

    FDA classification
    FDA Class 2 ·A Chemical Vapor Sterilization Multivariable Chemical Indicator

    JKM International, Inc.

    FDA registration
    JKM International, Inc.·1 product·🇨🇳 China

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170813·ROUND KNURLED HANDLE

    EKM INFLATION DEVICE

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207626·EKM INFLATION DEVICE

    EKM INFLATION DEVICE

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207619·EKM INFLATION DEVICE

    QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.

    FDA Enforcement
    Class II ·Ongoing·SEDECAL SA·May 8, 2024

    MEDIDENTA

    FDA UDI
    HANDPIECE PARTS & REPAIRS, INC.·00810988030735·STAR COMPATIBLE TITAN MOTOR 5K

    KM Medical

    FDA registration
    KM Medical·47 products·🇨🇦 Canada

    KM HEALTHCARE

    FDA registration
    KM HEALTHCARE·3 products·🇰🇷 South Korea

    KM SUPPLIES

    FDA registration
    KM SUPPLIES·1 product·🇺🇸 United States

    MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM

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

    QUANTA LITE LKM-1 ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    WI-75 E/KM

    FDA UDI
    W & H Dentalwerk Bürmoos GmbH·J021102075501·Surgical Handpiece

    EUROIMMUN ANTI-LKM-1 ELISA(LGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

    FDA Enforcement
    Class II ·Ongoing·SEDECAL SA·October 29, 2025

    CA 20:1 L KM

    FDA UDI
    Bien-Air Dental SA·J00716007850011·CA and HP are intended to transmit and apply th...

    Anti-LKM-1 ELISA (IgG)

    FDA UDI
    EUROIMMUN Medizinische Labordiagnostika AG·04049016026808·

    WI-75 E/KM 20:1

    FDA UDI
    W & H Dentalwerk Bürmoos GmbH·J021102075581·Surgical Handpiece for Osstem

    QUANTA Lite® LKM- 1 ELISA

    FDA UDI
    INOVA DIAGNOSTICS, INC.·08426950593201·1. 1x LKM-1 ELISA microwell plate (12-1 x 8 wel...