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    I-STAT PROTHROMBIN TIME TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820203551·Channels Glide Path File NiTi

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717103551·Midway Select Disposable Diamonds 856-018M Pkg/25

    3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATOM INFA WARMER V-505

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SLIDE/FIXED HAMMER 700 GRAMS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·March 25, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·March 11, 2011

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTI

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 27, 2008

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024