BEUDAMED
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    InBody

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intraoral Scan Body MINI

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075229·

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540695215·UNIV.MAND.VAR. CHEEK RETRACTOR

    Screwdriver

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225007·4.0MM VPCS SCREWDRIVER, NON-CANNULATED

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165604·Thorlakson Simple Hand Retr DE

    16PW - Washington Gas - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White

    SYNCHROMED EL PROGRAMMABLE PUMP

    FDA Adverse Event
    Other ·NEURO·Product code LKK·May 4, 2004

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

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

    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·March 17, 2015

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 24, 2014

    COLLEAGUE PRE-P1.7

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    UNK - CAGE/SPACERS: SYNCAGE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MQP·November 9, 2020

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code FTL·December 21, 2022

    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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021