BEUDAMED
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    CENTERLINE BIOMEDICAL

    FDA registration
    CENTERLINE BIOMEDICAL·3 products·🇺🇸 United States

    IOPS Mobile Cart

    FDA UDI
    Centerline Biomedical, Inc.·00843152100002·The IOPS (Intra-Operative Positioning System) i...

    IOPS™

    FDA UDI
    Centerline Biomedical, Inc.·00843152102037·Indications for Use: The IOPS (Intra-Operative ...

    IOPS™ Software Application

    FDA UDI
    Centerline Biomedical, Inc.·00843152104000·The IOPS (Intra-Operative Positioning System) i...

    IOPS™

    FDA UDI
    Centerline Biomedical, Inc.·00843152101023·IOPS™ Catheter Simple Curve 1

    IOPS Viewpoint

    FDA UDI
    Centerline Biomedical, Inc.·00843152101108·Double Curve Catheter, 75 cm

    IOPS™

    FDA UDI
    Centerline Biomedical, Inc.·00843152101030·IOPS™ Catheter Reverse Curve 1

    IOPS™

    FDA UDI
    Centerline Biomedical, Inc.·00843152103003·IOPS™ Tracking Pad 1

    IOPS Viewpoint

    FDA UDI
    Centerline Biomedical, Inc.·00843152101061·Simple Curve Catheter, 75 cm

    IOPS Visionary System

    FDA UDI
    Centerline Biomedical, Inc.·00843152100057·The IOPS® Visionary system displays the positio...

    IOPS Viewpoint

    FDA UDI
    Centerline Biomedical, Inc.·00843152101078·Simple Curve Catheter, 125 cm

    IOPS®

    FDA UDI
    Centerline Biomedical, Inc.·00843152103027·IOPS Fiducial Tracking Pad is a sterile, single...

    IOPS™

    FDA UDI
    Centerline Biomedical, Inc.·00843152102013·IOPS™ Guidewire 2 Handle for connection of guid...

    IOPS®

    FDA UDI
    Centerline Biomedical, Inc.·00843152102051·Guidewire Handle

    IOPS Viewpoint

    FDA UDI
    Centerline Biomedical, Inc.·00843152101115·Double Curve Catheter, 125 cm

    INTRA-OPERATIVE POSITIONING SYSTEM (IOPS)

    FDA Adverse Event
    Injury ·CENTERLINE BIOMEDICAL·Product code DQK·November 7, 2025

    IOPS GUIDEWIRE ANGLED TIP 2

    FDA Adverse Event
    Malfunction ·CENTERLINE BIOMEDICAL·Product code DQX·June 13, 2023

    IOPS GUIDEWIRE ANGLED TIP 2

    FDA Adverse Event
    Malfunction ·CENTERLINE BIOMEDICAL·Product code DQX·June 13, 2023

    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

    FDA Enforcement
    Class I ·Ongoing·Centerline Biomedical Inc·May 28, 2025

    INTRA-OPERATIVE POSITION SYSTEM (IOPS)

    FDA Adverse Event
    Malfunction ·CENTERLINE BIOMEDICAL, INC.·Product code DQX·April 10, 2025