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    HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317300287·

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508055·

    AIM™FEMORAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868003349·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434502·Tasso+ allows self-collection of a capillary bl...

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161011420·Thin Reamer Handle

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101142141·ALLURE® MB Base Rx .022 UR4&5 -7T 0A 2D

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101142111·ALLURE® MB Base Rx .022 UR4 -7T 0A 2D HK

    Micro Milling Drum XXXF

    FDA UDI
    Spierings Orthopaedics B.V.·08720828234044·

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 21, 2003

    AUDIO TECHNOLOGIES S:R.1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AQUARIUS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    ELLIPSE VR, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·January 8, 2024

    SYRINGE 10ML 21G 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·June 17, 2021

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024