BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    Kisses Plus Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    LCP

    FDA UDI
    Synthes GmbH·10886982141194·1.8MM LCP BUTTRESS PIN 18MM

    Scalpel

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222785·Medial Spike Removal Tool

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307911·MXHO LINER 40-56/58

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457200420·Conic OSS

    Initia Total Hip System

    FDA UDI
    KYOCERA MEDICAL CORPORATION·04580810058621·"MXHO LINER 40-56/58 Size:40-56/58 Type:Elevate...

    ACUMED

    FDA UDI
    Acumed LLC·10806378013805·3.5mm x 34.0mm Cortical Screw

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306805196·Peet Cottle Rasp, Straight, Diamond Dust, 19cm

    ACUMED

    FDA UDI
    Acumed LLC·10806378013812·3.5mm x 34.0mm Cortical Screw

    OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OTOMAG BONE CONDUCTION HEARING SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 9, 2016

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 27, 2016

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2016

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·September 26, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 1, 2013

    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

    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026