BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 28, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 7, 2022

    KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT

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

    PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    RECOVERY FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 22, 2008

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 12, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    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

    DRX Revolution Mobile X-Ray System

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021