BEUDAMED
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    TEMPORARY CROWN AND BRIDGE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101267·Burs FGSL 6, Pkg/5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450287286·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450287293·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450258996·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540756213·12MM CORTEX REAMER TIBIAL

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    RANGER II M6, MODEL IN-888WNL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PALMLIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    INTELLANAV CATHETERS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OAD·November 22, 2023

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·March 25, 2013

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 16, 2011

    PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MJO·October 25, 2018

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012