BEUDAMED
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    Capnostream 35 Portable Respiratory Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003494·Diagnostic EP Catheter, Josephson curve, 5 elec...

    DUVAL COLLIN FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896061262·DUVAL COLLIN FORCEPS HORIZONTAL SERRATIONS

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925047075·nCare 4K Footswitch

    iSmile

    FDA UDI
    Ismile Dental Products, Inc.·00816419021440·VP Micro Brush Applicator Regular Green

    DIEGO POWERED DISSECTOR AND DRILL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    SACRAL NERVE STIMULATION DEVICES

    FDA Adverse Event
    Other ·MEDTRONIC NEUROMODULATION·Product code EZW·September 21, 2007

    MERIT MANIFOLDS

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 21, 2011

    MERIT MANIFOLDS

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 21, 2011

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 1, 2013

    200594-6F 5 5 5 170 PENT JOS EZ

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (GLENS FALLS)·Product code DRF·May 18, 2000

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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