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

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    PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPACT MODULAR

    FDA UDI
    Biomet Orthopedics, LLC·00880304304512·

    ENDOTRACHEAL TUBE CHANGERS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PULSEMASTER ERBIUM DENTAL LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 24, 2020

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 16, 2019

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

    VCARE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·August 6, 2008

    SOFLEX SILICONE SQUARE EDGE FOLDABLE LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·July 14, 2006

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 25, 2022

    SENSATION PLUS 8FR. 50CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION 7FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 6, 2025

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017