BEUDAMED
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    CURA-Temp

    FDA 510(k)
    FDA Class 2 ·Dental

    iTero Element 2

    FDA UDI
    Align Technology, Inc.·00816063020288·

    NA

    FDA UDI
    Synthes GmbH·10886982145222·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

    BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI

    FDA 510(k)
    FDA Unclassified ·Unknown

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 27, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·August 11, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 2, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    COBAS E411 RACK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·June 7, 2010

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    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