BEUDAMED
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    SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT SURESTEP METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 31, 2011

    OT SURESTEP ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 11, 2011

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 14, 2010

    MedGyn IUI

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803022724·mini iui

    SSCOR, INC.

    FDA registration
    SSCOR, INC.·4 products·🇺🇸 United States

    SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273

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

    NUMALINK

    FDA 510(k)
    FDA Class 2 ·Radiology

    S-SCORT III

    FDA Adverse Event
    Malfunction ·SSCOR, INC.·Product code BTA·October 19, 2004

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·March 27, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 17, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 27, 2008

    3002682307-2018-00185

    FDA Adverse Event
    Malfunction ·July 31, 2018

    DISCARDIT¿ II SYRINGE W/O NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 15, 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

    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

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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

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