BEUDAMED
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    ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

    FDA 510(k)
    FDA Class 2 ·Hematology

    RAM® COR-SUTURE® QUICK LOAD®

    FDA UDI
    LSI Solutions, Inc.·00850200006766·RAM® COR-SUTURE® QUICK LOAD® SINGLES 5MM, PLEDG...

    ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAICHEM GLUCOSE UV REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN PARIETEX PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 27, 2021

    VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015

    2520274-2013-11033

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MNI·March 27, 2013

    CE INTERMATE LV 250, 24 PACK,50126

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 17, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 1, 2008

    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