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

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    Astrasono A3Pro Bladder Scanner (A3Pro)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455943·Integra® Jarit® Stille Type Gouge, 8", 14mm Wide

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250331030·ceraMotion® Paste 3D Gingival 2 / dental cerami...

    CHBS

    FDA UDI
    aap Implantate AG·04042409454042·Screw rack CHBS 4.5/5.0, empty

    18ch T/R Knee Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADHESIVE 1

    FDA 510(k)
    FDA Class 2 ·Dental

    MSS - HUMERAL REVERSE LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 14, 2014

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·September 15, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 26, 2013

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·May 10, 2024

    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Arrow Three-Lumen CVC

    FDA Enforcement
    Class II ·Terminated·ARROW INTERNATIONAL Inc.·July 6, 2022

    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·September 18, 2024

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023