BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Ponto Bone Anchored Hearing System, MONO Surgery Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Ophthalmic Hooks

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113820·VISCO CANNULA 25GA ANGLE 8MM

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361021179·Arena-C HA, 11X17 Lordotic, 7mm

    CYSTOSCOPES

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

    MODIFICATION TO ALKP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AGX

    FDA UDI
    Widex A/S·05706069749809·Audigy AGXWU-IP (Light beige S-330 ) Right

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2024

    CAPSUREFIX NOVUS

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

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 3, 2013

    CPS/OSS 5CM TAPER ADAPT W/OSS SC

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 25, 2015

    OSS 3CM DIAPHYSEL SEGMENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·August 25, 2015

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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