BEUDAMED
    330 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·April 22, 2026

    CS100 IABP. Software Version CS100 IABP Q.01.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 11, 2026

    CS300 IABP. Software Version CS300 IABP C.01.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 11, 2026

    Cardiosave Rescue. Intra-Aortic Balloon Pump system.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·December 17, 2025

    Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·December 17, 2025

    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·September 10, 2025

    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

    FDA Enforcement
    Class II ·Ongoing·Volcano Corp·August 6, 2025

    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·July 16, 2025

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·June 25, 2025

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    FDA Enforcement
    Class II ·Ongoing·Meddev Corp·May 21, 2025

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    FDA Enforcement
    Class II ·Ongoing·Meddev Corp·May 21, 2025

    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·November 13, 2024

    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551

    FDA Enforcement
    Class II ·Ongoing·Embecta Corp.·July 31, 2024

    9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·July 17, 2024

    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·August 28, 2024

    NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

    FDA Enforcement
    Class II ·Ongoing·NovaSignal Corp.·July 3, 2024

    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

    FDA Enforcement
    Class II ·Ongoing·NovaSignal Corp.·July 3, 2024

    Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·March 27, 2024

    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

    FDA Enforcement
    Class II ·Ongoing·Newport Corp·June 12, 2024

    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·October 13, 2021