BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    Model 9100 PFT/DICO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FareTec Wheeled Litter Carrier

    FDA UDI
    FARETEC, INC.·B54122210300·FareTec Wheeled Litter Carrier, Military, green...

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989031317·SPRING COIL CLOSE WOUND PKG 010 X 030

    SIMPLEX/SARAL

    FDA UDI
    PARAMOUNT SURGICALS, INC.·00852647007795·1 LEVEL CERVICAL PLATE 30 MM

    ALIF Inserter

    FDA UDI
    XENCO MEDICAL LLC·B064XM12210301·

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315819191·XCyte 21, XCyting Human Mulicolor Band Probe

    EN SNARE

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011

    TITANIUM CANNULATED INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·August 23, 2011

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·July 11, 2013

    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021