BEUDAMED
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    SWIVEL ELBOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040043714·Curette McCalls DE 13S/14S

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005751·ISOLA SPINE SYSTEM OPEN HOOK 6.35 x 8.0mm

    Immunalysis

    FDA UDI
    IMMUNALYSIS CORP·00840937108932·Multi-Drug Calibrator 3

    TEKNO®

    FDA UDI
    Tekno-Medical Optik-Chirurgie GmbH·04044684022688·CRILE-WOOD NEEDLE HOLDER 15CM

    Electrode

    FDA UDI
    I.C. MEDICAL, INC.·00817688020899·

    QB1 NMES System

    FDA UDI
    Motive Health, Inc.·00854691008247·QB1 NMES System; 2XL/3XL, Right

    e-vive NMES System; 2XL/3XL, Right (2.0 Dock)

    FDA UDI
    Motive Health, Inc.·00854691008407·e-vive NMES System; 2XL/3XL, Right (2.0 Dock)

    BARCOMED 2MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CIRCULAR STAPLER, 33MM DIGITAL LOADING UNIT

    FDA Adverse Event
    Malfunction ·POWER MEDICAL INTERVENTIONS·Product code GDW·December 11, 2008

    LINER: MPACT FLAT PE HC LINER 32/F

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 12, 2013

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·February 18, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·February 19, 2008

    TROPONIN I (TPI) IMMULITE 2000

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code MMI·June 18, 2019

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000215, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000215, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017