BEUDAMED
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    DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Preclean Kit

    FDA UDI
    MEDIVATORS INC.·40677964007642·Preclean Plus Kit includes Pentax Air Water Suc...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040129944·Plugger DE Black 1/2

    t:slim X2 Insulin Pump with Basal-IQ

    FDA UDI
    Tandem Diabetes Care, Inc.·00853052007288·t:slim X2 Insulin Pump with Basal-IQ, Replaceme...

    Truliant

    FDA UDI
    Exactech, Inc.·10885862623720·Special Truliant DF FFG Uncaptured Anterior and...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450156278·

    BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    E3 MICROPROB SERIES OF LASERS AND ACCESSORIES

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

    INFINION? PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 28, 2025

    PULSE GEN MODEL 100

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 5, 2009

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    EASICATH CH12 MALE

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code GBM·February 24, 2011

    CD3200SL 110

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISON/CELLDYN·Product code GKZ·February 21, 2008

    OXF TWIN-PEG CMNTD FEM SM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·March 25, 2021

    OXF UNI TIB TRAY SZ B RM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·March 25, 2021

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 2012

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024