BEUDAMED
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    LIQUIBAND FLOW CONTROL

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

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176162397·Carbide bone cutter CA

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108965·Modular Spacer, 38 mm (W) x 30 mm (L) x 11 mm (...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159798·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197539722·Spurling Laminectomy Ronguer upwards ang led 5x...

    FUSTAR STEERABLE INTRODUCERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHESS HAND SURGERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 13, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 19, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    ULTRATHANE BILIARY DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 6, 2017

    ULTRATHANE BILIARY DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code GBO·March 3, 2021

    ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code GBO·July 18, 2017

    TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)

    FDA Enforcement
    Class II ·Terminated·TomoTherapy Incorporated·December 17, 2014

    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .

    FDA Enforcement
    Class II ·Terminated·TomoTherapy Incorporated·August 27, 2014

    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024