BEUDAMED
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    UNITRAX MODULAR UNIPOLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Affordable

    FDA UDI
    Keystone Industries·H66810142261·Pour Powder Heavy Veined 5 lb

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780781·LEVAMED ACTIVE ANKLE SUP SLVR L VI

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450822586·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573556·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573532·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573525·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573549·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573563·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142160·Trial, TLIF, 32L OB CRV 7Deg, 16mm

    VERDICT -II METHAMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CALIBRATOR FOR AUTOMATED SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·March 5, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·April 15, 2015

    Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·May 14, 2014

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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