BEUDAMED
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    NIGHTRON POLYSOMNOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    GERMIPHENE CORP.

    FDA registration
    GERMIPHENE CORP.·3 products·🇨🇦 Canada

    SURGASSIST FLEXSHAFT 2, MODEL FS2 14

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

    MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    2520274-2013-01657

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code FZX·March 26, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·March 26, 2008

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

    COOK-SWARTZ DOPPLER PROBE

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code ITX·September 6, 2015

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    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