BEUDAMED
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    Burn Navigator

    FDA UDI
    ARCOS, INC.·B2551143·Burn Navigator RX

    Burn Navigator

    FDA UDI
    ARCOS, INC.·B2551125·Burn Navigator H2 Transport

    Burn Navigator

    FDA UDI
    ARCOS, INC.·B2551120·Burn Navigator H2 model

    ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWA·January 28, 2011

    Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Recall
    Terminated ·Arcos, Inc·Product code PDT·March 16, 2015

    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Enforcement
    Class II ·Terminated·Arcos, Inc·August 28, 2019

    European Healthcare & Device Solutions Ltd.

    Authorized representative
    🇮🇪 Ireland·66 Manufacturers·867 Devices

    Acro Biotech Inc.

    Manufacturer
    🇺🇸 United States·3 Importers

    ACRO BIOTECH Inc.

    FDA registration
    ACRO BIOTECH Inc.·138 products·🇺🇸 United States

    ANATOMAGE GUIDE

    FDA Adverse Event
    Injury ·ANATOMAGE·Product code NDP·November 22, 2016

    NONTEMPLATE ALIGNER ARCH

    FDA Adverse Event
    Injury ·DENTSPLY SIRONA ORTHODONTICS INC.·Product code NXC·February 19, 2025

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·February 7, 2022

    BYTE NIGHT ALIGNERS

    FDA Adverse Event
    Injury ·STRAIGHT SMILE, LLC·Product code NXC·October 30, 2024

    BYTE NIGHT ALIGNERS

    FDA Adverse Event
    Injury ·STRAIGHT SMILE, LLC·Product code NXC·November 24, 2024

    Ink, Arch Tracing

    FDA classification
    FDA Class 1 ·Ink, Arch Tracing

    LOOP TIP SURGICAL CAUTERY, STERILE, HIGH TEMPERATURE

    FDA Adverse Event
    Other ·ABCO DEALERS, INC.·Product code GEI·December 24, 2003

    ABCO BATTERY OPERATED CAUTERIES

    FDA Adverse Event
    Injury ·ABCO DEALERS, INC.·Product code GEI·July 16, 2007

    THC Rapid Test Cassette

    FDA UDI
    ACRO BIOTECH INC·00853691007168·THC Rapid Test Cassette

    BZO Rapid Test Cassette

    FDA UDI
    ACRO BIOTECH INC·00853691007120·BZO Rapid Test Cassette

    COC Rapid Test Cassette

    FDA UDI
    ACRO BIOTECH INC·00853691007137·COC Rapid Test Cassette