BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120242501·Carbide, cylinder round, crown cutter for preci...

    Disposable Mouthpiece 29mm OD

    FDA UDI
    Vacumed·00850644007299·cardboard mouthpiece

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725503485·New split bundling patient end disposable strap...

    Flex

    FDA UDI
    Diversified Products, Inc.·00037741502463·

    MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)

    FDA 510(k)
    FDA Class 2 ·Dental

    7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114

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

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2024

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019

    FR MARSEILLE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 27, 2013

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·March 3, 2011

    SIGMA 8000

    FDA Adverse Event
    Malfunction ·SIGMA INTL.·Product code FRN·March 27, 2008

    UNK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011

    FR VILLEURBANNE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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

    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