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

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    Cosmolock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm

    DATACAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0130100·Plate Holder

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710630130190·2nd TMT Joint Cut Guide, 13mm x 19mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710640130190·3rd TMT Joint Cut Guide, 13mm x 19mm

    STERILE SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    REMSTAR PRO C-FLEX+

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 6, 2025

    TRIATHLON PS X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 20, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·March 4, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 15, 2014

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 18, 2025

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 18, 2025

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 18, 2025

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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