BEUDAMED
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    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964153358·Endo Carry-on Procedure Kit contains Intercept ...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014363·Zirlux 16+ A2 98.5X25

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033262160·

    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    ULTRA V THERAPEUTIC ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 14, 2026

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 8, 2026

    FREESTYLE FLASH

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

    ILS 33MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 19, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 8, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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