BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    MODEL 9200 RESPIRATION/HEART RATE MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083012151·STR, 10 electrode, MPD-S, 2-5-2mm electrode spa...

    NA

    FDA UDI
    Stryker GmbH·04546540370655·Plate Rack

    Stern EX Acid Etched Implant NP 3.3x11.5mm, Direct Delivery, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549108976·The Sterngold Acid Etch Dental Implant System c...

    ARIX Elbow System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

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

    OASIS

    FDA Adverse Event
    Injury ·HITACHI MEDICAL CORPORATION·Product code LNH·July 9, 2015

    CUSA EXCEL 23KHZ STRAIGHT HANDPIECE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES IRELAND LIMITED, SRAGH, TULLAMORE, CO.·Product code LFL·May 6, 2014

    COROX OTW-L 85-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code DTB·January 2, 2013

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019