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

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    CAPNOMAC ULTIMA ANESTHESIA MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981194390·Interbody, 9mm x 32mm x 9mm, 8 deg

    WaveForm TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981243555·Interbody, 9mm x 32mm x 9mm, 8 Deg, 3D

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981209506·Trial, 9mm x 32mm x 9mm, 8 deg

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981202385·Interbody, 9mm x 32mm x 9mm, 8 deg

    N-ACETYLPROCAINAMIDE ASSAY FOR COBAS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK SPIRIT COMBO CARTRIDGE

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013

    HEM-O-LOK TAKEAPART ENDO APPLIER LG 10MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·November 29, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 1, 2014

    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