BEUDAMED
    15 results · 34ms · Sources: EU EUDAMED, US FDA

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    PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556601723·SOD CANNULA 7MM HIP W/TPRD TIP

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094010855·Welch Allyn Ear Wash System with Hydrovac Actio...

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118790·

    Elite® Bondable Buccal Tubes

    FDA UDI
    Ortho Organizers, Inc.·00190707070670·Elite®.018 L7L MINI DB

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024201668·

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CERNER PROVISION WORKSTATION (VERSION 2.5)

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENERAL MIS SPHERE INSTRUMENT SET

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·June 12, 2019

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 30, 2014

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 10, 2010

    PARIETEX UGYTEX PP 15X10CM X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·December 6, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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