BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

    FDA 510(k)
    FDA Class 2 ·Hematology

    APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICONNECTION 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·October 29, 2008

    CONCEPT SUTURE PASSER NEEDLE

    FDA Adverse Event
    Injury ·CONMED LINVATEC·Product code LXH·August 16, 2011

    DAVINCI SURGICAL ROBOT

    FDA Adverse Event
    INTUITIVE SURGICAL INC·Product code NAY·July 3, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023