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

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    MINUET LCD, MINUET LCD eco

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Drill Sleeve

    FDA UDI
    I.T.S. GmbH·09120069812824·Drill Sleeve, D=5.1mm, Cannulated Femur Nail

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987169125·CORTICAL SHANK, Cannulated, 8.0 X 75

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981169121·CORTICAL SHANK, Cannulated, 8.0 X 75

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 4, 2023

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694042956·Neuropack, Profile Zero, 3 Straight Plates, 6 A...

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210173863·Rod, 3.5mm x 75mm

    BINAXNOW COVID-19 SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·May 18, 2022

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 4, 2023

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 16, 2023

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Manual TruCut Biopsy Cannula

    FDA UDI
    Möller Medical GmbH·04260277173333·

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277171711·

    BINAXNOW COVID-18 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code QKP·December 23, 2022

    PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, PR·Product code DQE·July 27, 2011

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code LIT·June 13, 2013

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2008

    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    FDA Enforcement
    Class II ·Ongoing·IsoTis OrthoBiologics, Inc.·January 22, 2025