BEUDAMED
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    SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA

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

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717102691·Air Water Syringe Tips White (250) - (plastic i...

    Cortera Spinal Fixation System

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311247158·Tray, Full, Cann, INS, Level 3

    ELECSYS CORTISOL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TREMOROMETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    Kinesia One

    FDA UDI
    Great Lakes Neurotechnologies Inc.·00859584006041·Kinesia One, Tablet Assembly, WiFi plus Cellular

    LIFESTENT 5F VASCULAR STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·February 20, 2023

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·March 25, 2013

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIO·March 16, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·March 25, 2008

    Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr. Model # CT-0020-270 Item # RFC270020. Manufactured by Medpro International (Thailand) Ltd.

    FDA Recall
    Terminated ·Wolf Medical Supply Inc.·Product code MEB·October 20, 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

    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