BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier Cavity Prep

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008272·CPI Hatchet-Black DE_BC 51/52

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312261·

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003017·Jacobson Micro Needle Holder Flat Handle

    DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLUM 360¿ INFUSER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FRN·February 6, 2025

    SYRINGE 30ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 22, 2020

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 28, 2011

    INFINITY GAMMA PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL SYSTEMS, INC.·Product code DRT·February 25, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026