BEUDAMED
    29 results · 25ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Bernafon

    FDA UDI
    Bernafon AG·05714464009534·BERNAFON ALPHA 7 MNR T R SABE/MAC

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025057·G85 Mini Incubator

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM

    SPHERZ

    FDA 510(k)
    FDA Class 2 ·Neurology

    IFUSE IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCLERAL BUCKLING PRODUCTS: STYLE 41, 3.5MM SILICONE STRIP

    FDA Adverse Event
    Injury ·D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV·Product code HQX·March 16, 2018

    1222074-2018-00243

    FDA Adverse Event
    Injury ·December 26, 2018

    SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE

    FDA Adverse Event
    Injury ·D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV·Product code HQX·March 16, 2018

    EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)

    FDA Adverse Event
    Malfunction ·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA·Product code HQC·March 9, 2020

    DIRECTIONAL LASER PROBE WITH DORC CONNECTOR (25 GAUGE / 0.5 MM)

    FDA Adverse Event
    Malfunction ·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.·Product code GEX·June 12, 2020

    ILLUMINATED STEPPED LASERPROBE, 23G / 0.6 M WITH ALCON® CONNECTOR

    FDA Adverse Event
    Malfunction ·DUTCH OPHTHALMIC USA·Product code HQF·June 29, 2017

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 3, 2014

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·November 6, 2008

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    FDA Adverse Event
    Malfunction ·CARDIANBCT·Product code LKN·August 16, 2011

    EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)

    FDA Adverse Event
    Malfunction ·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA·Product code HQC·May 21, 2020

    EVA VITRECTOMY PACK VGPC INPUT 25G

    FDA Adverse Event
    Malfunction ·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.·Product code HQC·August 4, 2021

    BACKFLUSH INSTRUMENT

    FDA Adverse Event
    Malfunction ·D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.·Product code HMX·July 8, 2020