BEUDAMED
    396 results · 43ms · Sources: EU EUDAMED, US FDA

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    COLUMBUS REVISION KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASCENDENT ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·March 29, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·May 27, 2021

    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code JOW·May 3, 2013

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 21, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 6, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·March 24, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·June 15, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·May 18, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·June 7, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 2, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 16, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 28, 2021

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·Product code MNT·November 24, 2020