BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PERSONAL ECG TRANSMITTER, MODEL CG-6550

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 11, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·June 17, 2008

    GO BED PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 11, 2011

    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 2110. 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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023