BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    CLEANSE S+ ULTRASONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306801495·Adson-Brown Forceps - 7x7 Teeth, 2.0 mm Tip, Fe...

    Acessa ProVu System

    FDA UDI
    Hologic, Inc.·15420045515314·The Acessa ProVu Console Dual Foot Pedal

    Acessa ProVu Dual Foot Pedal

    FDA UDI
    ACESSA HEALTH INC.·00854763006256·Pneumatic foot pedals with tubing used to turn ...

    DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CBYON SURGICAL OPERATING SYSTEM (SOS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    OPTETRAK KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 11, 2025

    CONTOUR CURVED CUTTER STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code GDW·April 10, 2013

    1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MQN·September 4, 2014

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·April 15, 2011

    BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022