BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    CLEARPATH ALIGNER

    FDA 510(k)
    FDA Class 2 ·Dental

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540492036·LOCKING SCREW, CROSS-PIN

    Matreneu® Percutaneous Balloon Compression Kit

    FDA UDI
    Shenzhen Shineyard Medical Device Co.,Ltd.·06939698601425·This product primarily consists of five parts, ...

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052348·3.5mm x 14mm Poly Screw Assm. The Atoll OCT Spi...

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166452·Polyaxial Screw, 3.5mm x 14mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376657103·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 14mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040741·Screw - Self-Drilling - 3.5x14mm

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376536156·SPS VA Self-Drill Screw, 3.5 x 14 mm

    PRO-V COAT

    FDA 510(k)
    FDA Class 2 ·Dental

    TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATOLL CERVICO-THORACIC SYSTEM

    FDA Adverse Event
    Malfunction ·SEASPINE ORTHOPEDICS CORPORATION·Product code KWP·May 13, 2021

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    PROTECTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code NIK·June 14, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    BARDIA® FOLEY CATHETER SILICONE COATED

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·June 6, 2024

    BARDEX® LUBRICATH® FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·June 6, 2024

    BARDIA® FOLEY CATHETER SILICONE COATED

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·June 6, 2024

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·August 14, 2017