BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

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

    HHM

    FDA UDI
    Oticon A/S·05707131351463·G500 SC, BTE PP 13 2.4G 105 C057 HHM

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704001904·CODMAN SLIM-LINE Aneurysm Clip 45 Degree Angle ...

    Symmetry Cushing

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482057667·Symmetry® Retractor, Cushing Vein, 12.0 mm, 9 1...

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365118920·

    DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

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

    ASTRA TECH IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    MAXIMO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    HEARTSTART ONSITE

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 25, 2012

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023

    DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·September 12, 2018

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022