BEUDAMED
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    Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRYPHON

    FDA UDI
    Medos International Sàrl·10886705001491·GRYPHON Fishmouth Guide

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551110620·HALO, 1203-5 VEST PED1, ACRYLIC LINER, 1211-1 X...

    Straight Plate, 4.5mm

    FDA UDI
    I.T.S. GmbH·09120034304811·Straight Plate, 4.5mm, 7-Hole

    VERTEBRAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOSPA TIBIAL BASE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

    ANEURX STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·October 27, 2015

    LINOX SD 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2014

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 23, 2008

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026