BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ERA Angled 2.2mm Implant Micro 10X1mm, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107139·The ERA implant enables the transitional functi...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111438387·SIEBOLD SCISSOR S-CVD 9 1/2"

    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    ALARIS PCA MODULE

    FDA Adverse Event
    Injury ·CAREFUSION CORP·Product code FRN·June 18, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 17, 2010

    ACTIVELIFE

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·May 4, 2020

    ACTIVELIFE

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·May 4, 2020

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 2, 2025

    STEALTHSTATION S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 13, 2021

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021