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    AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150494·Endo Carry-on Procedure Kit Includes Basin, Int...

    RESPONDER 5, INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828182263·RESPONDER 5, INTERACTIVE

    RESPONDER 5, INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828173834·RESPONDER 5, INTERACTIVE

    EPPENDORF SE

    FDA registration
    EPPENDORF SE·2 products·🇩🇪 Germany

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008109·

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal

    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

    FDA Adverse Event
    FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 23, 2025

    COCR BALL HEAD IMPLANTS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 15, 2025

    FREESTYLE

    FDA Adverse Event
    Malfunction ·RABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    HYDROVIEW INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·March 14, 2013

    HEARTMATE II LVAD

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·March 1, 2011

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    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