BEUDAMED
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    KNH Surgical Face Mask

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981197438·Smooth Shank Poly. Screw, 3.5mm x 28mm

    SANARUS CORE TISSUE BIOPSY SYSTEM

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

    NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gibralt®

    FDA UDI
    INNO Holdings, Inc.·M711050002035280·Posterior Cervical Screw Assembly, 3.5mm X 28mm...

    Gibralt

    FDA UDI
    Choice Spine, LP·10885862145055·

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·June 15, 2022

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 16, 2022

    CVC KIT: 2-LUMEN 15 FR X 28 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code MSD·October 17, 2008

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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