BEUDAMED
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    ENDOPOUCH RETRIEVER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Herculink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648078262·RX Herculink Elite Renal and Biliary Stent Syst...

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619023249·Sterile Cap (Single)

    Herculink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648078248·RX Herculink Elite Renal and Biliary Stent Syst...

    Herculink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648078255·RX Herculink Elite Renal and Biliary Stent Syst...

    Tempro Blue

    FDA UDI
    Spident Co., Ltd.·08809262954173·Light cured, single component, provisional fill...

    4.0 X 115mm CANN SCREW FASTENER Ti SH THD

    FDA UDI
    Osteocentric Technologies, Inc.·00810074303347·4.0 X 115mm CANN SCREW FASTENER Ti SH THD

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 18, 2025

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 29, 2025

    TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALPCO MILENIA ANTI-TPO ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 15, 2025

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    CD HORIZON

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 14, 2007

    NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 19, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 7, 2011

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 30, 2020

    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    FDA Recall
    Terminated ·OrthoPediatrics Corp·Product code HSB·August 19, 2019

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015