BEUDAMED
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    BAKER CKMB REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011845024000·dentaform® Bands Central Upper right No. 24

    NA

    FDA UDI
    Zimmer, Inc.·00889024102286·

    WHEELCHAIR MECHANICAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SERVOMED BASIC BEDSIDE UNIT SMV 110TP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Zimmer, Inc.·00889024074415·

    NA

    FDA UDI
    Zimmer, Inc.·00889024074422·

    NA

    FDA UDI
    Zimmer, Inc.·00889024074439·

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014

    CURLIN INFUSION 6000 PAINSMART IOD IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·October 24, 2012

    COOK

    FDA Adverse Event
    Injury ·Product code DQX·September 22, 2010

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006

    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