BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    SCANLAN SUTURE BOOTS

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

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725544914·Mindray Compatible BeneView T5, T8 SpO2 Sensor,...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664829625·Reusable SpO2 Sensor/Mindray/Y-type Multi-site/...

    Cabo™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508101581·4 LEVEL PLATE 80mm

    Cabo

    FDA UDI
    Seaspine Orthopedics Corporation·10889981160586·4 Level Plate, 80mm

    ATEC Universal Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PDE PHOTODYNAMIC EYE

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

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972113·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971604·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971611·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973585·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972106·

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZB·May 6, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 20, 2010

    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