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

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    S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131354341·G300 S, MINIRITE T 312 2.4G C044 HHM

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154732302·TENSION SHEATH FOR MP SYSTEM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120105900000·Cannulated Probe

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523141524·SL Universal Acetabular Trial Shell, 59mm

    NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 27, 2023

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 1, 2011

    HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INC·Product code FMJ·September 16, 2014

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 22, 2012

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024