BEUDAMED
    18 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700511·GC Initial™ MC Dentin DA1, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700805·GC Initial™ MC Dentin DA1, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·10888867312828·Guidewire, Trocar, 1.6mm

    Arthrex

    FDA UDI
    Provision·B504OMAR18700510·

    ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VENOSET FOR I.V. FAT EMULSION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION 15ML SAMPLE SIZ

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·NEURO - VILLALBA·Product code LGW·June 12, 2014

    XENIUM 190G SYNTH HF DIALYZER

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION USD·Product code KDI·October 15, 2010

    MAYFIELD INFINITY SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·December 10, 2012

    LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021