BEUDAMED
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    MOTION TRACKING

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717102936·Midway Select Disposable Diamonds 837-014C, Pkg/25

    MFCD 120

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Injury ·MATORHTO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    BD¿ GRAVITY IV SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·December 9, 2021

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·March 25, 2013

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·TRIVASCULAR, INC.·Product code MIH·August 19, 2014

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·March 25, 2008

    Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JLW·March 5, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 3, 2020

    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·June 13, 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

    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