BEUDAMED
    19 results · 26ms · 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.

    ATAC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030621·FRESH, SIZE XXL, SABBIA, MICRO-MASSAGING SHORTS...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120306211·Diamond, cone round, medium grit

    ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

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

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136322·Ti-6Al-4V ALIF Implant 30 X 26, 21mm Height 16°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137435·Trial, 30 X 26, 21mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138333·Broach, 30 X 26, 21mm Height 16° Hyperlordotic

    Widex

    FDA UDI
    Widex A/S·05706069879179·WIDEX EVOKE ERB2D DEMO (Silver Grey ) 220, Tele...

    CORTICAL LOCKING SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HRS·April 27, 2018

    BOOMERANG PEEK FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

    CORTICAL LOCKING SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HRS·April 27, 2018

    3D MAX MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 22, 2013

    NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·March 18, 2011

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·April 16, 2008

    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024