BEUDAMED
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    DIAPLUS Universal

    FDA 510(k)
    FDA Class 2 ·Dental

    Mini Twin

    FDA UDI
    Rmo, Inc.·00885797652805·ROTH MINI LOW PROFILE 022 HK/3 5-5 20EA

    Richard-Allan® Needle Straight Cutting

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113219216·Intent to be used with suture material for tiss...

    TLC Uni Knee Tibial Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077099·

    K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ORTHO-1(NOT FINALIZED)

    FDA 510(k)
    FDA Class 2 ·Dental

    CASPIAN Spinal System

    FDA UDI
    VB Spine LLC·10888857310155·Dual Action Rod Reducer

    SAIPH® KNEE

    FDA Adverse Event
    Malfunction ·MATOTHO LTD.·Product code JWH·January 16, 2020

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·August 12, 2011

    TAMPAX COMPAK TAMPON, REGULAR UNSCENTED

    FDA Adverse Event
    Other ·HYGINETT HUNGARIAN AMERICAN CO·Product code HEB·June 14, 2013

    CORDLESS DRIVER 3

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·October 30, 2014

    INSORB 30 STAPLER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GAG·March 19, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024