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

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    FLOWER SMALL AND MEDIUM IMPLANT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131256522·NERA, MINIBTE 312 WL 85 STG

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450201640·

    RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40

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

    STRYKER SPINE OASYS BONE SCREW

    FDA 510(k)
    FDA Unclassified ·Unknown

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    O.B TAMPONS PROCOMFORT REGULAR

    FDA Adverse Event
    Malfunction ·MONTREAL SAN PRO·Product code HEB·May 29, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    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