BEUDAMED
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    SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006208·ISOLA SPINE SYSTEM CLOSED HOOK 6.35 x 9.5mm

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022529·Wheatley's Trichrome Stain Set

    STRYKER PRECISION THIN SAW BLADE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS·Product code GFA·September 5, 2023

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361019954·Facet Screw Assy, SOTW, 5.0 x 25mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166190054·Drill, 12.5mm

    JET PORT PLUS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315810464·CL CDKN2A, 4x conc., 125µl

    S-ROM*STM STD,36NK,14X09X130

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 26, 2021

    STANDARD STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·June 26, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    2250051-2008-00069

    FDA Adverse Event
    Malfunction ·Product code JTC·January 31, 2008

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024