BEUDAMED
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    KLINIDRAPE REINFORCED SURGICAL GOWNS

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

    PowerPICC Provena

    FDA UDI
    Bard Access Systems, Inc.·00801741184970·Catheter Placement Kit

    Preclean Kit

    FDA UDI
    MEDIVATORS INC.·40677964007840·Preclean Plus Kit includes Brush, Pentax Air Wa...

    Tooth Tone

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730015488·SS Coated Lower 014 10 archwires per pack

    Mariner MIS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981255701·Driver Holder

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277132765·Jackson Ankle Distractor Vertical Table Rod

    MAGNA 5000 PHASED ARRAY CTL SPINE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CompressAR XTS Stand

    FDA UDI
    Semler Technologies, Inc.·10815614020286·The CompressAR XTS Stand is used with CompressA...

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037305867·HUMELOCK REVERSED END ROD CUP IMPACTOR

    2.4MM TI VA LOCKING SCREW STARDRIVE 10MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HRS·February 24, 2017

    OT VERIO IQ METER

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 12, 2014

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code MMI·March 7, 2023

    GRANUFLEX

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·October 4, 2022

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 21, 2022

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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