BEUDAMED
    28 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·October 30, 2019

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System V10 / **** / 347 BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01 BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191 BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·September 3, 2025

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·November 6, 2013

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 15, 2020

    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018