BEUDAMED
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    AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746160196·DB BKT MINI MS HGW UL BIC 022 T-7 A=0 R=0

    BROOKER FEMORAL NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THEKEN SMALL CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013

    LOW PROFILE CROSSLINK SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·March 29, 2011

    THERMOPHORE ARTHRITIS PAD

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·April 21, 2008

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018