BEUDAMED
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    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Safco Supergrade Secure Masks

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310209673·Safco Supergrade Secure earloop masks, blue, 50...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221063564·Mini Uni-Twin(TM) Bracket APC(TM) II LL3 -11T/5...

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221094582·Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -11T...

    4635 ASSISTANT'S INSTRUMENTATION

    FDA 510(k)
    FDA Class 1 ·Dental

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·March 19, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 16, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 26, 2008

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD MULTITEST¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·February 9, 2024

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·October 12, 2021

    BD MULTITEST¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024

    BD MULTITEST¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·March 15, 2024

    BD MULTITEST¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D

    FDA Enforcement
    Class II ·Ongoing·CAREFUSION·September 22, 2021

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017