BEUDAMED
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    POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496022442·WONDER MODEL 140 OPAQUE, SIZE L, CAMEL, GRADUAT...

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    MODIFICATION TO CLEARFIL SE BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 27, 2025

    ESTEEM

    FDA Adverse Event
    Other ·ENVOY MEDICAL·Product code OAF·March 12, 2013

    REPLY DR

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code DXY·March 17, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP·Product code CBK·March 26, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014