BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515018334·Hoyt Hemostatic Fcps, delicate jaw, curved, 19m...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973851·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970904·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970898·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973141·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973318·

    LUMINOS AGILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DYNAPBV BODY SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·March 18, 2021

    COBAS E 411 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 15, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OYC·October 3, 2014

    LOCKING SCREW VARIAX FULL THREAD 2.7MM / L16MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HRS·June 3, 2013

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 22, 2011

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 2, 2025

    COBAS E 411 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 28, 2016

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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