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    MASIMOSET LNCS NEO NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 5, 2024

    VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·June 12, 2013

    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    Starch-Dye Bound Polymer, Amylase

    FDA classification
    FDA Class 2 ·Starch-Dye Bound Polymer, Amylase

    BREEZE C MODEL C (3W), BREEZE C (4W)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CIM MED GMBH

    FDA registration
    CIM MED GMBH·1 product·🇩🇪 Germany

    CAW 3000

    FDA UDI
    Nouvag AG·ENOU5010NOU0·Contra angle for surgery wires CAW 3000

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236004439·White Nylon Insert-Standard Retention(2 pk)

    CHARLES PERY & CIE

    FDA registration
    CHARLES PERY & CIE·6 products·🇫🇷 France

    MIELE & CIE. KG

    FDA registration
    MIELE & CIE. KG·1 product·🇩🇪 Germany

    QardioArm

    FDA UDI
    QARDIO, INC.·00854894005104·

    Alira Medical Devices

    FDA UDI
    Alira Medical Devices, LLC·G767CBW1010·Cervical Bone Waxer | 216mm

    SHINING3D®

    FDA UDI
    Shining 3D Tech Co., Ltd.·06970163082707·

    AIW WATER SYSTEM FOR HEMODIALYSIS

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

    GENESIS BI-WING AAP

    FDA UDI
    Infinitus Medical Technologies LLC·00195893257713·

    C.W. Mathews - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588150604·C.W. Mathews - 18 Metal

    CIS COMPUTERISED IMAGING SERVICES PTY LTD

    FDA registration
    CIS COMPUTERISED IMAGING SERVICES PTY LTD·3 products·🇦🇺 Australia