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    BELTER BLOOD PRESSURE METER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANNU-FLEX

    FDA UDI
    Smith & Nephew, Inc.·00885554002737·MTO CANNU-FLEX GDE WIRE TROCAR TIP

    MICROLINE FLEXIBLE LIGATING SHEARS

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

    TI CLIP APPLIER

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

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 29, 2013

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·June 20, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015