BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    MASTERKA 40 MASTERKA 35 MASTERKA 30

    FDA 510(k)
    FDA Unclassified ·Unknown

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003365·65 V2 MEDIUM 22OD STRGT W/HG

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045340·Curved Sizer, 13mm

    Stablecut®

    FDA UDI
    SYNVASIVE TECHNOLOGY, INC.·00846795002207·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493902·

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104844·PS2 Screw 5.5mm x 35mm

    IBED WIRELESS WITH IBED AWARENESS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMTRAC; DELPHIN; SEMTRAC 2000 SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    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

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 15, 2013

    NATURALYTE

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

    NK II CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 1, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    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