BEUDAMED
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    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

    AT HOME DRUG TEST, MODEL 9079

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CT CORD IQ OPTION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA·Product code MNI·April 17, 2013

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code LXH·April 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

    GRASPIT UROLOGICAL GRASPING FORCEPS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FFL·July 22, 2008

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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