BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377062642·RELINE C Screw, 4.0x10mm Reduction

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704289435·

    Needle Holder

    FDA UDI
    KOROS U.S.A., INC.·10840199540409·Ryder Needle Holder 25.5cm 10"

    Eye Shield

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111130·EYE SHIELD W/ GARTER ASSORTED PACK OF 50

    EMPI MODEL 712, LOGIX(TM), NMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SURGICAL ASPIRATOR KIT

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 22, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 15, 2013

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·January 12, 2011

    ARCOM XL 44-36 STD HMRL BRNG

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·August 22, 2017

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·August 22, 2017

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·August 22, 2017

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021