BEUDAMED
    32 results · 29ms · 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 Status: Ongoing ×

    Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

    FDA Enforcement
    Class II ·Ongoing·Stryker, Inc.·February 21, 2024

    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

    FDA Enforcement
    Class II ·Ongoing·Stryker, Inc.·February 21, 2024

    Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·October 16, 2024

    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 11, 2023

    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·June 5, 2024

    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·June 5, 2024

    The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·June 12, 2024