BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743694·ACHIMED ACHILLES SUPP SILVER VI

    Safco Illusion Plus Composite

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310202463·Safco Illusion Plus A2 Syringe 4g

    Midway Everyday

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717102561·Midway Everyday Mixing Tips Green (48)

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036019648·

    RADIOCAMERAS EXTRACRANIAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alteon

    FDA UDI
    Exactech, Inc.·10885862549310·

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    ANI [ A&I ] GROUP TAIWAN·Product code IOR·March 25, 2013

    OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code MBI·March 11, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC·Product code LXH·March 26, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 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 Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021