BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    7600 V MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750001125·7600 SM FF W/AAV 22OD QREL HDG

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G223M1132390·Castroviejo Lachrymal Dilator DBL/Ended Lachrym...

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231132390·Castro Lacrimal Dilator Double End With One Sha...

    NEO UL Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837044831·Neo-UL Variable Angle Drill Guide

    IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 3, 2011

    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

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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 L231, PROPONENT DR EL MRI Pacemaker

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