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

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    INFUSION SYRINGE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131256560·NERA, MINIBTE 312 WL 85 TC

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055314·1.6mm Orbital Floor Plate, Fan, .2mm Thick

    5M MEDICAL FLAT PANEL DISPLAY, ME511L

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYRAY HYPERION

    FDA 510(k)
    FDA Class 2 ·Dental

    HAHN TAPERED IMPLANT Ø4.3 X 16 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 11, 2024

    HAHN TAPERED IMPLANT Ø4.3 X 16 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 11, 2024

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 29, 2013

    TARGET TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·December 10, 2013

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015