BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

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

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

    BioCare Safety Needles

    FDA UDI
    BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

    External Fixation

    FDA UDI
    Life Spine, Inc.·00190837023188·Straight Plate, 4 Hole

    OSTEOGRAF/LD-300

    FDA 510(k)
    FDA Class 2 ·Dental

    TARGON FN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    PLUM A+ ITALIAN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 14, 2011

    FREESTYLE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 22, 2008

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 31, 2023

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 2, 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