BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    EASYSPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00610171·

    n/a

    FDA UDI
    Ortho Development Corporation·00822409074815·12/14 Cemented Broach 10x17

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409011964·STD 10x17mm Stem Cemented

    STRAIGHT PLATE, 17-HOLE

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029062·

    InTess L

    FDA UDI
    Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square

    PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·April 16, 2013

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·June 12, 2008

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Other ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 8, 2011

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018