BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813035870·Reamers With Silicone Stops 31MM #30

    Bosma Enterprises

    FDA UDI
    Bosma Enterprises·00818634025425·Opportunity Pro Nitrile Exam Glove Large 100/Box

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756025546·Needle Counter

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197494366·Micro Scissors curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197494373·Micro Scissors curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197494380·Micro Scissors curved...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250803700·ceraMotion® One Touch Set Pink / dental ceramic...

    BEAR and BEAR mini

    FDA 510(k)
    FDA Class 2 ·Neurology

    PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M9307250803010·Custom Probe

    MAMMOTOME EX HOLSTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·December 2, 2008

    ASR ACETABULAR IMPLANT 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 29, 2013

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020