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

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    SQUALE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591011024·Neoprene Hinged Knee Wrap, Large

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707022855·CALIBRA BANDS 2ND MOLAR n.SUL 26

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471159392·N Nat M Loop 019X025 24Mm Lo

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471159408·N Nat M Loop 019X025 26Mm Lo

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471159422·N Nat M Loop 019X025 30Mm Lo

    Spreader 17mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215067748·

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471159415·N Nat M Loop 019X025 28Mm Lo

    REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable ECG Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 8, 2025

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 20, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·November 12, 2008

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 31, 2011

    SUNBEAM

    FDA Adverse Event
    Injury ·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·July 11, 2013

    DAVINCI SI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 20, 2022

    Positron Emission Tomography and Computed Tomography System, Model: uMI 550

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023