BEUDAMED
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    BOSWORTH AIR POLISHER

    FDA 510(k)
    FDA Class 1 ·Dental

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131101·IN-OVATION® C Base Rx 018 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531101·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531601·IN-OVATION® C Roncone 018 U5-5/L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531111·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531001·IN-OVATION® C Base Rx 018 U5-5/L3-3

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131611·IN-OVATION® C Roncone 018 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531611·IN-OVATION® C Roncone 018 U5-5/L3-3 CS-BC HK

    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013

    ESTEEM 1PC - 1PC DRAINABLE INVISICLOSE DRAINABLE POUCH APS

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EZQ·September 12, 2014

    LAMITRODE 4 LEAD, 90CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 18, 2011

    DELTAFILL18 6MM X 25CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 17, 2020

    The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.

    FDA Recall
    Terminated ·Ascension Orthopedics, Inc·Product code KYI·July 12, 2010

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024