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    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...

    MODIFICATION TO NASAL-AIRE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    nSpire Health

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

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

    SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXGEN LPS FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 20, 2013

    RENAISSANCE 26 P-WASS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·February 15, 2011

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code JJE·March 31, 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

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    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