BEUDAMED
    21 results · 22ms · 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 ×

    CAPTIA SYPHILIS-G ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

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

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00152051·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001525·artVeneer life lower anteriors, UIL, D4

    RHINOCELL® Epistaxis Packing

    FDA UDI
    Boston Medical Products, Inc.·EBESEP10015250·Size: 10.0 x 1.5 x 2.5 cm

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    LIFECARD CF COMPACT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK OFLOXACIN 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·October 26, 2007

    SEXTANT SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

    FREESTYLE FREEDOM

    FDA Adverse Event
    Injury ·Product code NBW·October 22, 2010

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 14, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·Product code NBW·December 10, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·January 27, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 20, 2008

    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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025