BEUDAMED
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    MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488296043·IV START KIT

    ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECSYS DHEA-S CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    RICH-MAR WINNER CM2

    FDA Adverse Event
    Injury ·RICH-MAR·Product code IPF·March 1, 2012

    AS COLUMBUS REV F FEMUR ZEMENTIERT F5L

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·November 6, 2019

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013

    D.A.S.H. DOME TIP DOUBLE LUMEN SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON-WILSON MEDICAL INC·Product code KNS·February 4, 2011

    PFC SIGMA STAB INS SZ2 8MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 13, 2008

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024