BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    Opera Evo

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I

    SprintRay High Impact Denture Base - Dark Meharry

    FDA UDI
    Sprintray, Inc.·00850039704215·SprintRay High Impact Denture Base is a light-c...

    Conventional Lead Apron .5mm Xtra Large 25 X 40

    FDA UDI
    Flow X Ray Corporation·00843696123758·Conventional Lead Apron .5mm Xtra Large 25 X 40...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112663·BARRON CORNEAL PUNCH 8.75MM

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 12, 2023

    LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WILLI GELLER CREATION & AV PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    TWIST MAX MTX 5.0 X 10 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 23, 2024

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    UNK

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 21, 2014

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 2, 2013

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 16, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 15, 2013