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

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    ESCOM 100

    FDA 510(k)
    FDA Class 2 ·Dental

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306816338·Balfour Retractor, Open Ended Blades, 10cm Deep...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL-7 COLOR SCREEN HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 29, 2015

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 15, 2011

    RDS3 DOCKING STATION

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 17, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 25, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 20, 2011

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024