BEUDAMED
    20 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

    FDA Enforcement
    Class II ·Terminated·Western / Scott Fetzer Company·July 2, 2014

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017

    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·September 14, 2016

    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

    FDA Enforcement
    Class II ·Ongoing·Fujifilm Irvine Scientific, Inc.·November 24, 2021

    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

    FDA Enforcement
    Class II ·Ongoing·Allergan PLC·December 11, 2019

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    FDA Enforcement
    Class II ·Terminated·Allergan PLC·February 10, 2021

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    FDA Enforcement
    Class II ·Terminated·Covidien, PLC·March 27, 2019

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    FDA Enforcement
    Class II ·Ongoing·Medtronic, PLC·March 11, 2020

    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.

    FDA Enforcement
    Class II ·Ongoing·Rocket Medical Plc·December 24, 2025

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·September 21, 2016

    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

    FDA Enforcement
    Class II ·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018

    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP, 27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0, 27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0, 27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5, 42812 - VALVE 42812 DELTA SMALL LEVEL I, 42813 - VALVE 42813 DELTA SMALL LEVEL 1.5, 42814 - VALVE 42814 DELTA SMALL LEVEL II, 42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP, 42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, 42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP, 46812 - ASSY 46812 DELTA SHUNT SMALL PL 1, 46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5, 46822 - ASSY 46822 DELTA SHUNT REG P/L 1, 46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5, 46824 - ASSY 46824 DELTA SHUNT REG P/L 2, 46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1, 46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5, 46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2, 92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0, 92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·February 24, 2021