BEUDAMED
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    Bolt Medical, Inc.

    Manufacturer
    🇺🇸 United States

    Bolt Medical Inc.

    FDA registration
    Bolt Medical Inc.·1 product·🇺🇸 United States

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723039·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723022·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723053·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723015·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723046·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723084·Intravascular Lithotripsy Console

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723091·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723008·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723060·Intravascular Lithotripsy Catheter

    SEISMIQ™

    FDA UDI
    Bolt Medical, Inc.·00850056723077·Intravascular Lithotripsy Catheter

    SEISMIQ

    FDA Adverse Event
    Malfunction ·BOLT MEDICAL, INC.·Product code PPN·May 6, 2026

    SLOTTED FIXATION BOLT WRENCH RINGFIX

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·December 21, 2015

    SARA 3000

    FDA Adverse Event
    Malfunction ·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·July 31, 2012

    SPIRIT PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS·Product code FNL·June 30, 2015

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·September 29, 2016

    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·December 24, 2014

    INFUSOMAT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 16, 2020

    LUMEX

    FDA Adverse Event
    Injury ·BLISS HEALTH PRODUCTS CO., LTD·Product code ITJ·September 29, 2016