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

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    ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741920500·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674192050060·

    Bernafon

    FDA UDI
    Bernafon AG·05711584087244·ZR1, KIT 312 2.4G NFM PB R BE ZERENA 1

    LMA AIRWAY MANAGEMENT

    FDA UDI
    TELEFLEX INCORPORATED·15060112317993·LMA Protector™ Cuff Pilot™ Size 5

    LMA AIRWAY MANAGEMENT

    FDA UDI
    TELEFLEX INCORPORATED·05060112313875·LMA Protector™ Cuff Pilot™ Size 5

    LMA AIRWAY MANAGEMENT

    FDA UDI
    TELEFLEX INCORPORATED·15060112311007·LMA Protector™ Cuff Pilot™ Size 5

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111265150·STILLE TISSUE FCP 4X5 5"

    ORTHOFIX MODULSYSTEM

    FDA UDI
    ORTHOFIX SRL·18053340345187·SS TRANSFIXING PIN L260MM D4MM THREAD D5XL50MM QC

    IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01

    FDA 510(k)
    FDA Class 2 ·Immunology

    Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6

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

    ORTHOFIX MODULSYSTEM

    FDA UDI
    ORTHOFIX SRL·18053340345200·SS TRANSFIXING PIN L260MM D4MM THREAD D5XL50MM ...

    CADD EXT SET TUBING

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·January 18, 2022

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

    R3

    FDA Adverse Event
    Injury ·SMITH AND NEPHEW, INC·Product code LZO·August 4, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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