BEUDAMED
    58 results · 18ms · Sources: EU EUDAMED, US FDA

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    DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013

    DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013

    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·March 7, 2018

    ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.

    FDA Enforcement
    Class III ·Terminated·Convatec Inc.·August 28, 2013

    Centurion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Legion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Infinity FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    LAUREATE World Phaco System

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·September 21, 2016

    FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·January 27, 2016

    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·January 27, 2016

    FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·January 27, 2016

    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·June 15, 2016

    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.

    FDA Enforcement
    Class III ·Terminated·Convatec Inc.·August 28, 2013

    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.

    FDA Enforcement
    Class I ·Terminated·Convatec Inc.·June 25, 2014

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Enforcement
    Class II ·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012

    INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750274, 8065750278, 8065750280, 8065750281, 8065751009, 8065751010, 8065751011, 8065751716, 8065751717, 8065751718, 8065751719, 8065751720, 8065751721, 8065751722, 8065751723, 8065751724 The INFINITI Vision system is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·December 10, 2014

    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·December 24, 2025

    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray

    FDA Enforcement
    Class II ·Terminated·Custom Assemblies Inc·August 30, 2017

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    FDA Enforcement
    Class II ·Ongoing·Custom Medical Specialties, Inc.·March 1, 2017

    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015