BEUDAMED
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    LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139249075·UNITY KNEE™ PS-C INSERT - Size 7T-8F x 11mm

    POWER TEK II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPRO POLAR HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NIO·August 5, 2025

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494589·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494572·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494565·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494558·

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    HC DISPOSABLE WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 20, 2013

    STOCKERT 70 RF GENERATOR

    FDA Adverse Event
    Malfunction ·STOCKERT GMBH·Product code DRF·June 10, 2011

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 15, 2008

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015