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

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    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)

    Ziehm Vision RFD 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184124·Accufit Molar Bands Lower Left Second Molar 36

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

    CLOUD CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 12, 2022

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

    AVELI

    FDA Adverse Event
    Injury ·REVELLE AESTHETICS, INC.·Product code OUP·August 11, 2023

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·August 11, 2011

    BIOMET

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MRA·October 10, 2008

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAE·September 18, 2023

    VALIANT NAVION

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 21, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·October 2, 2024

    REPLICA SM STAT SHT RT 10.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 21, 2023

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021