BEUDAMED
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    HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Gerald Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896116979·Gerald Forceps Tungsten Carbide Serrated Platform

    Incision Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222075·Incision Guide, MTA

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540356574·DRILL GUIDE,LAG SCREWS,1.6MM PILOT DRILL

    N/A

    FDA UDI
    NORTHGATE TECHNOLOGIES INC.·00817183020738·CO2 Hose and Yoke, Insufflation

    EVOLVE EPS ORTHOLOC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SERRALNYL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 28, 2023

    10FR FIXEDPIN HEMOSTATIC PROBE

    FDA Adverse Event
    Malfunction ·GYRUS ACMI L.P.·Product code KNS·April 20, 2023

    KAPPA 700 DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·October 16, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 10, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013

    CLARITY CONSOLE

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY-SAN JOSE·Product code LLZ·January 7, 2019

    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018