BEUDAMED
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    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20609401·Arch wires Titanol Budget mand. .016"

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70609401·Mini Sprint-Brackets Roth .022" 1000 Brackets 3...

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862284952·LOGIC CC FEM STEM TRIAL SIZE 4 RIGHT

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862626141·TRULIANT CC MODULAR FEMORAL STEM TRIAL SIZE 4 R...

    SEALAPEX 4

    FDA 510(k)
    FDA Class 2 ·Dental

    HUMAN SERUM ALBUMIN (HSA)

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

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011

    FORTE CPS 200 COMBO

    FDA Adverse Event
    Other ·CHATTANOOGA GROUP·Product code IPF·June 11, 2008

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022