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

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    ADDITIVE CAP (2B8905)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Photonica Professional

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPR RVS GLENO 2-PRNG INS/IMP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWS·September 10, 2019

    DUROM US ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 7, 2014

    ACCU-CHEK ADVANTAGE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 12, 2007

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2012

    HYBRID GLENOID IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWA·September 10, 2019

    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·April 9, 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

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025