BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743601·LEVAMED ANKLE SUPPORT SAND III

    SIMPLICT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152269·Endo Carry-on Procedure Kit contains Revital-Ox...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890108130·Zirlux Mutli Unit Driver

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450543948·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237120·

    FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·March 14, 2013

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code JOH·March 2, 2011

    RIATA ST PASSIVE FIXATION LEAD

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

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·October 23, 2025

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 17, 2025

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018