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    VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496061588·FREE LEGS, SIZE ML, CHAMPAGNE, MICRO-MASSAGING ...

    SURETONE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 18, 2019

    TM SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LPH·April 11, 2013

    HI-TORQUE ADVANCE GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·April 18, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 17, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024