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

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    DIGITAL FOREHEAD THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814756·GENUMEDI EXTRA WIDE SAND SIZE VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    AGXO

    FDA UDI
    Oticon A/S·05707131165176·K130, BTE 13 P SGR AGXO

    LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS

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

    MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THORACIC GRASPER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·May 26, 2011

    ARCOS 3.5MM HEX DRIVE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·December 19, 2022

    ARCOS 3.5MM HEX DRIVE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·December 19, 2022

    S5 CONSOLE FOR 4 PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DWA·December 16, 2016

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    S5 ROLLER PUMP

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWB·October 3, 2016

    SORIN C5 SYSTEM

    FDA Adverse Event
    LIVANOVA DEUTSCHLAND·Product code DTQ·July 7, 2016

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021