BEUDAMED
    4 results · 60ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).

    FDA Enforcement
    Class II ·Terminated·Sequent Medical Inc·November 2, 2016

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class II ·Terminated·B Braun Medical, Inc.·September 18, 2013

    Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change Kit, REF 74636C Central Line Dressing Kit, VCU, REF 57647B Central Line Removal Kit, REF 78631B Chest Tube Cleaning Kit, REF 73000 CVC Dressing Change Kit, REF 80643D Dressing Change Kit, REF 71538 ED Suture Set, REF 59299C Laceration Kit, REF 59806B Laceration Tray, REF 56957 Laceration Tray, REF 57888B Laceration Tray, REF 59387 Laceration Tray, REF 59387B Laceration Tray, REF 69477B Laceration Tray, REF 71582 LACERATION/SUTURE REMOVAL, REF 72347 LACERATION/SUTURE REMOVAL, REF 72347B Pediatric Central Line Dressing Kit, REF 74635C PICC Central Line Dressing Kit VCU, REF 59589C PICC/CVC/Central /Dialysis Clear Sequence Dressing Kit, REF 78197 Suture Kit, REF 59836 Trach Care Kit, Kit de Traqueostomia, REF LH_68162B Trach Care Tray, REF 56791B Trach Care Tray, REF 75378 Tracheostomy Care Tray, REF 4129 Tracheostomy Tray, REF 80209 Wound Care Kit, REF 68330 Wound Care Tray, REF 68358 MEDICHOICE: Tracheostomy Kit, Reorder: TRAC1002 THERAPY SUPPLY HOUSE: VAD DRESSING CHANGE KIT, Reorder # 76512B

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries, Inc. 306·January 15, 2020

    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics, Inc.·July 17, 2013