BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER

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

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·04049958003851·400 micron Holmium Laser Fiber Cable, Reusable,...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780828·LEVAMED ACTIVE ANKLE SUP SLVR R IV

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142140·Trial, TLIF, 32L OB CRV 7Deg, 14mm

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574034·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574027·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574041·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574010·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574003·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033573990·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112340·Tap, 6.50mm, Fixed Sleeve

    BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICROJET CRONO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 6, 2013

    VICTORY XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 18, 2014

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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¿ 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