BEUDAMED
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    STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040001547·MaxiTemp HP Kit

    Pearson

    FDA UDI
    Keystone Industries·H668D6401281·Pearson D-1 Lt Blue Hve 10/100

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001284·artVeneer life lower anteriors, UCL, B4

    Vista

    FDA UDI
    Modus Medical Devices Inc·G34350012841·15cm PET Jar & Lid -box of 18

    Palisade Pedicular Fixation System

    FDA UDI
    SPINEOLOGY INC.·M7401001284·Stylet Wrench

    SILK, NONABSORBABLE, SURGICAL SUTURES, USP

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

    TRANS FX ADJUSTABLE PIN TO BAR CLAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 27, 2019

    M2A 38-MM MODULAR HEAD- UNK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 14, 2012

    M2A 54-MM POROUS CUP-UNK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 14, 2012

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC·Product code JJE·February 24, 2011

    OCTOBASE RETRACTOR RACK

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIAC SURGERY TECHNOLOGIES·Product code DWS·February 15, 2008

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·September 4, 2013

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

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

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