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

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    EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073384·Carbide Bur FG 171L

    PULL THRU 4.8MM CASSETTE REFILL (180X12)

    FDA UDI
    MEDIVATORS INC.·40677964021556·

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470025981·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.3...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161322256·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.3...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496002598·NAOMI 140, SIZE XL, MOKA, GRADUATED COMPRESSION...

    5F GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION

    FDA 510(k)
    FDA Class 2 ·Dental

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    ANIMAS CORPORATION·Product code LZG·March 13, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·February 8, 2008

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 7, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 7, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 7, 2024

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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