BEUDAMED
    18 results · 33ms · Sources: EU EUDAMED, US FDA

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    PlasmaBlade TnA Tonsil and Adenoid Dissection Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Inspire™ Esthetic Provisional Composite A35

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003968·Esthetic Provisional Composite

    Inspire™ Esthetic Provisional Composite A35

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010528·Esthetic Provisional Composite

    ECG

    FDA UDI
    Zoll Medical Corporation·00847946021832·ASSY, CABLE, 12 LEAD ECG LIMB LEAD, 10FT, AAMI,...

    BUILD-IT TOTAL CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    SAFETY SCALPEL, #11 500/CASE, 500/DOUBLE POLYBAG

    FDA Adverse Event
    Malfunction ·S&S SURGICAL PRODUCTS INC·Product code GDX·August 9, 2024

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008

    MITEK RIGIDFIX

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·January 21, 2014

    UNKNOWN_NEUWAVE

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·November 12, 2024

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021