BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    OMNI ARC MONOBLOCK HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131261052·H10, MINIRITE 312 WL CBE

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046047·DreamWear Full Mask, Medium, with Medium Frame ...

    MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    ACX DOUBLE CHAMBER TISSUE EXPANDER

    FDA Adverse Event
    Injury ·SIENTRA, INC·Product code LCJ·May 24, 2013

    UNKNOWN DEPUY 35MM PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·June 13, 2011

    MICROTEK, GAMMA PROBE COVER

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICAN, S.A.·Product code KKX·January 8, 2015

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015