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

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    VICTUS LASER PLATFORM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1204260·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193235·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971369·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973233·

    CARESCAPE MODEL V100 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSD WIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 22, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    PRODISC-C IMPLANT LARGE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE PLANT·Product code MJO·June 3, 2011

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    EXPRESSEW III W/O HOOK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·July 24, 2020

    ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·August 29, 2012

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024