BEUDAMED
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    IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OCTAGON Infinity BL RC Burn-out plastic coping for bridge/bar, Ø 6.5 mm

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50221181·BL RC Burn-out plastic coping for bridge/bar, Ø...

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113478·PS-C Insert, Size 1 x 18mm

    STOCKERT COMPACT SYSTEM VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CADD EXTENSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·December 23, 2024

    CADD EXTENSION SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 11, 2025

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN PILLCAM

    FDA Adverse Event
    Injury ·GIVEN IMAGING LTD., YOQNEAM·Product code NEZ·May 12, 2022

    CADD EXTENSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·January 13, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 26, 2013

    SECURE ACUTE CARE BED 3/01

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

    BIPOLAR LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 25, 2008

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code NVN·May 7, 2022

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·May 7, 2022

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·June 13, 2022

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    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