BEUDAMED
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    IRON/TOTAL IRON BINDING CAPACITY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010522·Fixed, 10 electrode, MPB, 2-5-2mm electrode spa...

    Printed Lower ROC Pack for Herbst LR5 12mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015610·

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978079653·DISTRACTOR 901-561 SGL BARREL OS 20/12MM

    Elite®Opti-MIM® Bondable Buccal Tubes

    FDA UDI
    Ortho Organizers, Inc.·00190707069902·.022 LR SOLO TUBE 0T OPTI-MIM DB

    TX1 TISSUE REMOVAL SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COBAS 8000 E602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 30, 2014

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 8, 2013

    S8 ELITE - AMERICAS

    FDA Adverse Event
    Malfunction ·RESMED LTD.·Product code BZD·November 10, 2010

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    FDA Adverse Event
    Malfunction ·CORDIS SANTA CLARA·Product code MGB·July 28, 2022

    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 27, 2012

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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