BEUDAMED
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    S&T SINGLE USE MICRO ANASTOMOSIS CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746077203·LIGATURE 20 STICK TOOTH COLOR 50/BAG

    NICOLET PIONEER TC8080

    FDA 510(k)
    FDA Class 2 ·Radiology

    EZ SET INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COPIOS BONE VOID FILLER - PASTE

    FDA Adverse Event
    Injury ·KENSEY NASH CORP.·Product code MQV·March 22, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    LARGE VOLUME I.V. ADMINISTRATION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD, INC. (FORMERLY DELTEC, INC)·Product code FPA·March 31, 2008

    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

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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