BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    WOUNDWASH SALINE SPRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    Leukomed®

    FDA UDI
    BSN medical GmbH·04042809803020·LEUKOMED SKIN SENSITIVE STERILE 8X15CM WHITE 10

    Sensation

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730003003·Sensation Roth 022 LR4/5 Hk Rx -17° Tor. 0° Ang...

    Sensation M

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730011336·Sensation M Roth 022 LR4/5 Hk Rx -17° Tor. 0° A...

    CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 22, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2011

    LOCKSCR Ø5 SELF-TAP L36 TAN

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·January 1, 2020

    CORTSCR Ø4.5 SELF-TAP L36 TI

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·December 31, 2019

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 1, 2024

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 1, 2024

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Enforcement
    Class III ·Ongoing·NeuMoDx Molecular Inc·July 12, 2023

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·May 15, 2023