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

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    LENSX LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331166181·double-ended probe, stainless steel, 6" (15.0 cm)

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111358959·SKLAR POLISH 8OZ CS/12

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501996·Gutta Percha Points is used to root canal filin...

    PINN SECTOR W/GRIPTION 50MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 19, 2020

    CONCORD 72

    FDA 510(k)
    FDA Class 2 ·Dental

    DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

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

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 1, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    TEMA ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDC·July 26, 2024

    32MM 12/14 TPR FEM HD -4 NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·December 19, 2018

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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