BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    QLAB QUANTIFICATION SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Modelstar S

    FDA UDI
    S & S Scheftner GmbH·04260207853120·Powder 65, 5kg

    NexxZr™ T / D-100-35-NT-D300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113757·

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981204822·Trial, 11mm x 32mm x 16mm, 15 Deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981208097·Trial, 11mm x 32mm x 16mm, 15 deg

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981288952·Interbody, 11mm x 32mm x 16mm, 15 Deg, 3D

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981192983·Interbody, 11mm x 32mm x 16mm, 15 deg

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981190675·Interbody, 11mm x 32mm x 16mm, 15 Deg

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981200978·Interbody, 11mm x 32mm x 16mm, 15 deg

    SONTEC BAYONET NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896090293·SONTEC BAYONET NEEDLE HOLDER TUNGSTEN CARBIDE S...

    STERILE SALINE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VINTAGE AL

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUERESULT

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 6, 2017

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    COULTER AC*T DIFF 2 ANALYZER

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

    SPECIFIC DEVICE NOT REPORTED

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

    Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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

    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 Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021