BEUDAMED
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    MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    nSpire Health

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

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOWMEDICA OSTEONICS SHOULDER SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 22, 2022

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    MEGADYNE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·March 21, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 31, 2008

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·May 28, 2025

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

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

    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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018