BEUDAMED
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    HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964003309·The ENDO CARRY-ON Procedure Kit contains all of...

    PROLITE

    FDA UDI
    Atrium Medical Corporation·00650862300048·ProLite Mesh, 3in. x 3in. (7.5cm x 7.5cm)

    PediFlex

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132133323·PEDIFLEX STERILIZATION CASE - IMPLANTS AND INST...

    Valeo Spacer System

    FDA UDI
    SINTX Technologies, Inc.·M555316000303·Base, Phantom Plus PLIF, TLIF System Case 2

    CARDIOSAVE HYBRID, TYPE I PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 23, 2025

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209420963·FlowLogic Agile Shaping File 10 Variable, 21mm

    AVL OPTI R ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TORNIER TOTAL ELBOW PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    DUODOPA_DUOPA

    FDA Adverse Event
    Injury ·ABBVIE - MEDICAL DEVICE CENTER·Product code KNT·September 19, 2025

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·February 17, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·February 14, 2008

    PROLITE MESH 3"X3"

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·December 8, 2011

    TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·July 17, 2025

    INSORB 30 STAPLER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GAG·August 18, 2022

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017