BEUDAMED
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    IdentiTi ALIF Standalone Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA

    SCULPTURE PLUS NANO-HYBRID COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCELL EVO3 (FORMERLY ACCELL A2I)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·March 27, 2013

    SELECTION AFM

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 9, 2008

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021