BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776180140·TC ADSON FORCEPS SERRATED .

    ArgenZ ST 95x16 ML A1B

    FDA UDI
    ARGEN CORPORATION, THE·D818130236·Dental porcelain/ceramic restoration kit

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180616·Integra® Jarit® Adson Tissue Forceps, 4-3/4", C...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1302360·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450667507·

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STAIR SYSTEMS PACS & DICOM VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

    MICRUSFRAME10 6MM X 11.9CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 8, 2022

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 30, 2014

    SECURA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code LWS·June 16, 2011

    DIMENSION EXL WITH LM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

    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