BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    SpaceFlex Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804298·Double Prong Thimble Hook, Sharp, 18mm Left Hand

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402719·Guide Rod, Tibial Cone D16/L120

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·July 8, 1999

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 12, 2020

    EXPEDIUM SYSTEM, VIPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLAGEN DENTAL MEMBRANE IV

    FDA 510(k)
    FDA Class 2 ·Dental

    VORTEX PORT

    FDA Adverse Event
    Malfunction ·RITA MEDICAL SYSTEMS·Product code LJT·October 6, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·June 18, 2013

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024