BEUDAMED
    25 results · 54ms · 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 ×

    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL, MV-AZ80310HL, MV-AZ80410HL, MV-AZ80420HL, MV-AZ80620HL, MV-AZ80820HL, and MV-AZ81020HL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·October 2, 2013

    Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    SurFlo IV Catheter

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·May 10, 2017

    Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 3, 2013

    Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·May 10, 2017

    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·September 14, 2016

    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 3, 2013

    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·March 7, 2018

    SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.

    FDA Enforcement
    Class I ·Terminated·Terumo Medical Corporation·June 5, 2019

    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

    FDA Enforcement
    Class I ·Terminated·Terumo Medical Corporation·June 5, 2019

    Terumo Needle, 18G x 1", Product Code NN1825R

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 31, 2019

    Terumo Sur-vet Needle, 22G x 1", Product Code 100211

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 31, 2019

    Terumo Needle, 30G x 1/2", Product Code NN3013R

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 31, 2019

    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

    FDA Enforcement
    Class I ·Terminated·Terumo Medical Corporation·June 5, 2019

    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·July 31, 2019