BEUDAMED
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    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Recall
    Open, Classified ·Echopixel, Inc.·Product code LLZ·April 11, 2016

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 24, 2024

    Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code OFU·May 6, 2026

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NDW·February 9, 2022

    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CJY·February 9, 2022

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code LCP·February 9, 2022

    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024