BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·August 29, 2012

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Enforcement
    Class II ·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017

    NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·February 27, 2013

    NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff, Inc.·February 27, 2013

    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·January 14, 2015

    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·March 11, 2015

    Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·April 8, 2015

    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    APD Drain Manifold

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·June 8, 2022

    Automated peritoneal dialysis (APD) cycler

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·May 4, 2016

    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·January 25, 2017

    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·December 20, 2023

    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·October 9, 2019

    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·February 11, 2015

    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 22, 2014

    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016

    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016