BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECIFIC DEVICE NOT REPORTED

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

    NexxZr™ T / D-100-22-NT-D300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113719·

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981190651·Interbody, 11mm x 32mm x 16mm, 10 Deg

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981233501·Interbody, 11mm x 32mm x 16mm, 10 Deg, 3D

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981204808·Trial, 11mm x 32mm x 16mm, 10 Deg

    SONTEC BAYONET NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896021921·SONTEC BAYONET NEEDLE HOLDER TUNGSTEN CARBIDE S...

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981288938·Interbody, 11mm x 32mm x 16mm, 10 Deg, 3D

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450723104·

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BLUE SAIL INNOVATION

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 1, 2014

    TARGET DEVICE GAMMA3 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·May 29, 2013

    CLOSUREFAST CATHETER, 7F, 100CM

    FDA Adverse Event
    Other ·COVIDIEN·Product code GEI·June 3, 2011

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·June 26, 2024