BEUDAMED
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    TEMPBOND CLEAR WITH TRICLOSAN

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier SPRING PASTE FILLER

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053565·ROOT FILLER PKG 4 25MM 25-40

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844047·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTREAM FR2 AED, MODEL M3860A,M3861A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    TOTAL CARE SPORT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 17, 2011

    HAWKINS III BLN

    FDA Adverse Event
    Other ·MEDICAL DEVICE TECHNOLOGIES, INC.·Product code MIJ·May 29, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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