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

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    GEN_3

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ORTHOPEDIATRICS BLADE PLATE SYSTEM

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS·Product code HRS·October 3, 2017

    LIFELINES PHOTIC STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 3, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·March 24, 2025

    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