BEUDAMED
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    Nucleus.io

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114230·LASIK CANNULA FORMS 27GA 4-PORTS

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA

    PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228

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

    ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·June 16, 2020

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    FDA Adverse Event
    Malfunction ·MINNTECH CORPORATION·Product code NVE·October 17, 2008

    ATTAIN STARFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical Inc·May 11, 2016

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 21, 2019

    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021