BEUDAMED
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    INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109045·CAPSULE STAINING CANNULA 25GA

    MEDIPORT 2000 MOBILE

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

    FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 24, 2017

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 15, 2016

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 23, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 27, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    UNK

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·October 11, 2010

    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