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

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    HEALIX KNOTLESS ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003341·65 V2 PETITE 22ID ELBOW W/HG

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795002146·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045326·Curved Sizer, 11mm

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493889·

    GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SELF-COUNTERSINKING BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    EXPRESSEW III NEEDLE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code LXH·May 15, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    ADVANTAGE SERIES 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 24, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code ELC·April 29, 2020

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·May 31, 2023

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025