BEUDAMED
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    SLEEPSTRIP DISPOSABLE APNEA SCREENER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Astra

    FDA UDI
    Preat Corporation·00842092102428·Astra®-compatible Aqua 3.5/4.0mm Non-Engaging V...

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018499·FORCEP TISSUE #32 SEMKIN TAYLOR SERRATED CURVED...

    Preat

    FDA UDI
    Preat Corporation·00842092170311·Astra®-compatible Aqua 3.5/4.0mm Non-Engaging V...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002135·artVeneer life lower posteriors, M, D2

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167900021350·

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900021350·

    6F & 7F INTRODUCING CATHETERS (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRO.DUCT CATHETER, MODEL CTH03

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

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 14, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 11, 2017

    ACCUTRAK DELIVERY CATHETER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 11, 2017

    2520274-2013-10204

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code MNI·February 11, 2013

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·February 2, 2011

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·February 25, 2008

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS INC.·Product code LNR·July 2, 2015

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017