BEUDAMED
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    Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113691·CYSTOTOME FORMED 25GA

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 18, 2020

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 11, 2020

    CALEO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMTEC SENDAX MDI ORTHO6 AND ORTHO8

    FDA 510(k)
    FDA Class 2 ·Dental

    BD MAX SYSTEM, BD MAX INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code OOI·September 3, 2020

    SPRINT QUATTRO SECURE S

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

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·July 2, 2013

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 19, 2023

    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

    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

    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