BEUDAMED
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    T-STAT 303 ISCHEMIA MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057370496·STRETCHER PAD 24" W X 3.5" H X 74" L SOFTCARE PLUS

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve

    MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·April 26, 2013

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 23, 2008

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

    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