BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106330·Zirlux Titanium Esthetic Abutment Anterior comp...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450130629·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B073DRK0100330·Assembly, Navagio Fixed Draw Rod, Large Knob

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight

    YPSOPUMP INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 16, 2025

    YPSOPUMP INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 16, 2025

    SYNTHETIC GLASS BONE GRAFT MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000

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

    PROXIMAL HUMERUS, LEFT, 9X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·May 28, 2021

    BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 27, 2023

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 14, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·March 1, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BLUNT TIP SCREW, 4X38MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 8, 2021

    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

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018