BEUDAMED
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    WIRION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LCP

    FDA UDI
    Synthes GmbH·10886982141248·1.8MM LCP BUTTRESS PIN 28MM

    MICRO FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060470·MICRO FORCEPS WITH TYING PLATFORM ROUND HANDLE ...

    Nanoplasty System

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222884·Inserter

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165475·DEAVER RETR

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898306433·STD LINER 44-72/74

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780024835·Integra® Jarit® Deaver Retractor, 7-1/4", Pedia...

    CORTEK ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VagiVital Aktivgel

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

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 16, 2023

    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    FDA Enforcement
    Class II ·Terminated·Northgate Technologies, Inc.·May 13, 2020

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 21, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FFK·March 10, 2020

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020