BEUDAMED
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    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827882·***DISC*LEVAMED ANKLE SUPPORT BLACK VI

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151255·Endo Carry-on Procedure Kit contains Intercept ...

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450052730·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105060·Inserter Sleeve, All Size Implants

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024243·Lumbar Inserter, Inline- Lateral

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193022677·B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/U...

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193025869·HIP ACETABULAR FIXATION CUP - 66 MM 5 HOLE

    MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    5C-ES CELL CONTROL, MODELS 7547191, 7547192

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 13, 2025

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MFA·March 19, 2013

    EQUISTREAM ALPHACURVE DL CATHETER 14.5 FR, 28CM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD)·Product code MSD·March 1, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    FDA Recall
    Open, Classified ·Synovo Production·Product code KXB·May 30, 2023

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    FDA Enforcement
    Class II ·Ongoing·Synovo Production·April 17, 2024

    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