BEUDAMED
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    AMS SLING FIXATION SYSTEM

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

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109900·Zirlux Titanium Screw compatible with: Camlog S...

    DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES

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

    OPUS 10 DENTAL DIODE LASER

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

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 8, 2025

    ACIST

    FDA Adverse Event
    Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·March 19, 2013

    SYBRONPRO XRT

    FDA Adverse Event
    Injury ·EBI INC.·Product code DZE·March 8, 2011

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code KWT·May 26, 2026

    ACIST

    FDA Adverse Event
    Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012

    DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    FDA Enforcement
    Class II ·Terminated·Carestream Health, Inc.·January 29, 2014

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019