BEUDAMED
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    COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019891·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) A2

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161073714·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) A2

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 18, 2021

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 1, 2025

    SPERM WASH MEDIUM, CAT# 2003/2005

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    POLYMACON

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    APEXPRO TELEMETRY SERVER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·October 24, 2012

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·March 11, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGA·February 27, 2011

    ULTRAMINI

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·February 21, 2008

    Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 24, 2011

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024