BEUDAMED
    10 results · 36ms · Sources: EU EUDAMED, US FDA

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    Saf-T-Vac Smoke and Fluid Evacuator

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

    BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VALO CORDLESS

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    ECHELON*FLEX60 COMPACT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 21, 2011

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 14, 2014

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024