BEUDAMED
    26 results · 23ms · 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.

    GE VIVID - I

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189744·LEVAMED ACTIVE ANKLE SUP BLACK L V

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020171·MI-1000 Minor Surgical Light, Dual Ceiling

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020737·MI-1000 Minor Surgical Light, Dual Ceiling

    VISION LED

    FDA UDI
    Avante·00815871022194·DRE Vision LED, DUAL CEILING

    VISION LED

    FDA UDI
    Avante·00815871022231·DRE Vision LED, DUAL CEILING

    SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPTIA SYPHILIS-G ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SYSTEM 98XT, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

    SYSTEM 98XT

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

    MI-1000

    FDA Adverse Event
    Malfunction ·MEDICAL ILLUMINATION INTRNATION INC.·Product code FST·January 3, 2024

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 18, 2025

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 27, 2013

    EON RECHARGEABLE IPG, 16-CHANNEL

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 16, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·June 17, 2008

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026