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

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    Ultra RapidWarm™ Blast

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464056637·BERNAFON ALPHA 3 MNR T SABE/MSIL

    MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    UNKNOWN DEPUY DURA 32 CONSTRAINED LINER

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JDI·September 9, 2011

    1.1MM DRILL FOR 1.5MM SCREW

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HSZ·July 17, 2013

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·March 12, 2025

    VISIGLIDE2

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 21, 2026

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014