BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Dentium NR Line CAD/CAM Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    FIBERLASE C02 LASER WAVEGUIDE

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

    ARGON CONTINUOUS FLUSH DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEVEL 1 HOTLINE IV FLUID WARMER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LGZ·May 24, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 21, 2011

    PD1400 DEFIBRILLATOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·September 10, 2008

    BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSI·October 2, 2024

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025