BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE PILLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MATRIXMIDFACE SCREWDRIVER BLD SELF-RETAINING F/90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·Product code HXX·May 14, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 31, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 20, 2010

    TPRLC 133 T1 PPS HO 12X144MM 4MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 18, 2020

    TPRLC 133 T1 PPS SO 13X146MMTP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 2020

    TPRLC 133 MP TYPE1 PPS HO 15.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 2020

    TPRLC 133 MP TYPE1 PPS SO 17.0 1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 2020

    TPRLC XR MP T1 PPS 16X117MM 117MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·February 18, 2020

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023