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

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    Otoport Pro

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361029526·Ø12MM X 30MM HYBRID FUSION SCREW, SACROFUSE

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295122166·POLY REMOVAL TOOL

    740 SELECT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Precice® Ankle Salvage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·September 21, 2015

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 25, 2008

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    9.2MM FLUTED ACORN

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    SILK BRD BLK 15X60CM M2.0

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAP·December 19, 2019

    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·July 20, 2022

    ARROW Endurance Extended Dwell Peripheral Catheter System

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

    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

    Aspiration Syringe Kit, REF: MVSK60

    FDA Enforcement
    Class II ·Terminated·MICROVENTION INC.·November 10, 2021

    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

    FDA Enforcement
    Class I ·Ongoing·Percussionaire Corporation·November 6, 2024

    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 27, 2020

    Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

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

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

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

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

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