BEUDAMED
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    BTL-703-2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925046290·Digital Hub, nCare 4K, MD

    EVANS TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060777·EVANS TISSUE FORCEPS TUNGSTEN CARBIDE SERRATED ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036313·Drill/Driver Organ, M3-X, OPWR

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)

    BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 23, 2022

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·May 2, 2017

    3.5MM LCP PLATE 12 HOLE/157MM

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HRS·July 6, 2017

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·October 15, 2008

    COLLEAGUE PRE P1.7

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 1, 2013

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 19, 2021

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 19, 2021

    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

    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