BEUDAMED
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    MEDTRONIC AVE BRIDGE X3 STENT

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

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964005860·Endo Carry-on Procedure Kit includes Transport ...

    MicroEZ Introducer

    FDA UDI
    Bard Access Systems, Inc.·00801741140297·5 F MicroEZ Microintroducer

    GPS® III

    FDA UDI
    Biomet Biologics, LLC·00880304460645·

    Brite-Gear

    FDA UDI
    ORMCO CORPORATION·00889989023718·Facebow MINSHORT#4 044 WHITE

    ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS

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

    NIPRO INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    CADIERE FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 12, 2013

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    FDA Adverse Event
    Injury ·COVIDIEN / FORMERLY TYCO·Product code JOH·February 16, 2011

    840 VENTILLATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP·Product code CBK·February 21, 2008

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    ACRYSOF SINGLEPIECE IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·December 7, 2022

    MIX2VIAL TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·WEST PHARMA. SERVICES IL, LTD·Product code LHI·February 13, 2026

    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