BEUDAMED
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    AngioVac F18 85

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endobrushes

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2123861·Endobrushes Black. Suitable for LuxaBond Total-...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586025136·

    ACTICLOT PROTEIN S, MODEL 843L

    FDA 510(k)
    FDA Class 2 ·Hematology

    EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    COCR HD 12/14 +4MM NK 28MM MSL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 26, 2018

    *

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HTW·October 20, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    2520274-2013-04051

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·July 9, 2013

    ALLOFIT ALLOCLASSIC SHELL 52/I I

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·October 5, 2017

    CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·October 5, 2017

    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·October 2, 2013

    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code DYB·September 10, 2013

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025