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

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    BD Curve Ascites Shunt

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003340·MCK PATELLOFEMORAL TRIAL (5 LEFT)

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481122002·LOCATOR F-Tx Abutment For 5.0mm Platform Extern...

    Denovo Preformed Matrix Band

    FDA UDI
    Denovo Dental, Inc.·00810059291010·Denovo Preformed Matrix Band - Adult 1/4, Size 5

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL·Product code MGB·March 30, 2011

    MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    SAVINA

    FDA Adverse Event
    Injury ·DRAEGER MEDICAL GMBH·Product code CBK·June 7, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    LONESTAR RETRACTOR

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code GAD·May 22, 2023

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·April 8, 2021

    SYSTEM 2450

    FDA Adverse Event
    Injury ·CONSOLIDATED MEDICAL EQUIPMENT COMPANY·Product code GEI·September 16, 2024

    TELESCOPE SMOKE DISSECTOR STD

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·March 5, 2025

    ELECTROSURGICAL GENERATOR

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·March 5, 2025

    RTN ELEC SINGLE PLATE 9FT CORD

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·March 5, 2025

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024