BEUDAMED
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    ENVISION ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108696·Midway Select Explorer 2 Double End Standard Ro...

    PAXGENE® BLOOD CCFDNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 2, 2022

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARAMIS DERMATOLOGICAL LASER

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

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOS) MEMBRANE

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·March 20, 2013

    TWINFIX TI 5.0 MM RC

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY·Product code MBI·March 16, 2011

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·March 27, 2008

    COOK-SWARTZ DOPPLER PROBE

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code ITX·September 6, 2015

    PAXGENE® BLOOD CCFDNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 24, 2024

    PAXGENE® BLOOD DNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 26, 2023

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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.·November 2, 2016