BEUDAMED
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    HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00171301·

    Sonova Brand

    FDA UDI
    Sonova AG·07613389477016·myPhonak Junior app

    FLEXLINK ULTRAFLEX (ACCU-CHEK)

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 6, 2025

    MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Neurology

    IVC THREE BLASTOCYST MEDIUM, CAT # 2007

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2018

    *

    FDA Adverse Event
    Injury ·Product code LWS·September 17, 1997

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·March 11, 2013

    ARTICULATING HOOK WITH MONOPOLAR CAUTERY

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GEI·February 22, 2011

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 15, 2008

    Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code MHX·July 23, 2009

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015