BEUDAMED
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    8100/8500 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008508·Zirlux 16+ White 89x17x16

    ACUFEX

    FDA UDI
    Smith & Nephew, Inc.·03596010060815·STINGRAY PUNCH BASKET LEFT LOOP HANDLE

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369715·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2021

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.A DE C.V·Product code FPA·October 22, 2025

    ENGPLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    8300 ALARIS ETCO2 MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code CCK·January 21, 2021

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013

    3 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 14, 2011

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024