BEUDAMED
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    Indigo® Aspiration System - Lightning® Flash

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517196194·MaXcess 4 Retractor, Nrw Ant Short

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776189181·Hopkins II deg Telescope FBronchoscopy Esoph...

    C9--CHAMPION

    FDA UDI
    FGX INTERNATIONAL INC.·00031568475054·

    3.5mm HEX DRIVER WITH PADDLE HANDLE

    FDA UDI
    Osteocentric Technologies, Inc.·00810189110571·3.5mm HEX DRIVER WITH PADDLE HANDLE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694007504·Anterior Ridge Form Mesh, 11mm

    C9--CHAMPION

    FDA UDI
    FGX INTERNATIONAL INC.·00070135475059·

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023289·Ø8MM FUSION SCREW, GEN II, SACROFUSE, 30MM

    WiSe

    FDA UDI
    STRYKER CORPORATION·07613327056051·19 Inch HDTV Surgical Display

    NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT

    FDA Adverse Event
    Malfunction ·PERKINELMER, INC.·Product code QJR·March 5, 2021

    DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.

    FDA Recall
    Terminated ·Stryker Imaging·Product code LMB·July 31, 2009

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 3, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 8, 2011

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·September 6, 2023