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

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    ORALLITE COMPREHENSIVE EXAM TRAY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MEDRAD® Spectris Solaris EP MR Injection System

    FDA UDI
    BAYER MEDICAL CARE INC.·00616258008844·"MR INJECTOR, HIGH-PERFORMANCE BATTERY (60721015)"

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012070D0·12 x 70 mm Anodized SI Implant

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P30120700·Ti-Fix OLIF Spacer 30 x 12 x 7 (mm) x 0 °

    6.5 Cancellous Bone Screw, hex, St.Steel, L 70 mm

    FDA UDI
    mahe medical gmbh·EMAH00100120700·6.5 Cancellous Bone Screw, hex, St.Ste...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659174306·6.5 Cancellous Bone Screw, hex, _x000D_...

    12 x 70mm Anodized SI Implant

    FDA UDI
    Osteocentric Technologies, Inc.·00810097800045·12 x 70mm Anodized SI Implant

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 25, 2021

    ULTRAPAK NEHA

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIOLOK SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    BD PLASTIPAK¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 22, 2022

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 7, 2021

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    UNKNOWN DEPUY TIBIAL STEM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 20, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 14, 2011

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 22, 2021

    BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 2, 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

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014