BEUDAMED
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    INTEGRA MOZAIK AND OS MOLDABLE MORSELS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489112822·TrueForm Nitrile Exam Gloves, Small

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450390351·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450409183·

    ZOLL ONE STEP PACING CABLE

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL·Product code MLN·February 19, 2013

    ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RANDOX DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    VIZISHOT EBUS

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP·Product code FCG·September 2, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 17, 2011

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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