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    REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD

    FDA 510(k)
    FDA Class 2 ·Neurology

    Printed Lower ROC Pack for Herbst LL4 10mm,

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015750·

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083014650·Fixed, 10 electrode, S, 2-10-2mm electrode spacing

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978079684·DISTRACTOR 901-575 C-STYLE 22/14MM

    CMDR 2C (Multiple Models)

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IVORY CLAMP

    FDA Adverse Event
    Malfunction ·HERAEUS KULZER LLC·Product code EEF·June 30, 2014

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 4, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 10, 2010

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019