BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    Cerafix Dura Substitute

    FDA 510(k)
    FDA Class 2 ·Neurology

    TiN Coated Glenosphere

    FDA UDI
    FX SOLUTIONS·03701037300817·HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCRE...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507851·Gutta Percha Points is used to root canal filin...

    Zavation

    FDA UDI
    Zavation LLC·00842166106239·ALIF 15deg 36mmx13

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154940·WHITNEY 15deg 36mmx13mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166157163·HA+ ALIF 15deg 36mmx13

    Zavation

    FDA UDI
    Zavation LLC·00842166180611·ALIF Sizer 15deg 36mm x 13mm

    L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE

    FDA 510(k)
    FDA Unclassified ·Unknown

    INPECTRA STO2 SPOT CHECK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 1, 2022

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011

    BD PRE-FILLED SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 29, 2023

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty

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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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

    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