BEUDAMED
    25 results · 23ms · Sources: EU EUDAMED, US FDA

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    HEARTSPAN STEERABLE INTRODUCER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NexxZr™ T / D-100-30-NT-D300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113740·

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981190668·Interbody, 11mm x 32mm x 16mm, 5 Deg

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981204815·Trial, 11mm x 32mm x 16mm, 5 Deg

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2021

    DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEMOSIL PROTEIN S ACTIVITY ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·September 29, 2020

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·June 10, 2002

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 4, 2022

    BATT-HANDPIECE MOD F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GEY·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 17, 2011

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code HBC·March 26, 2018

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016