BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    RESUSCI INFLATE-A-SHIELD CPR BARRIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174221·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174121·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174201·

    COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNTHES ANTERIOR CSLP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 7, 2014

    HERO GRAFT

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·December 11, 2014

    HERO GRAFT

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·July 21, 2014

    HERO GRAFT

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·December 11, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·March 7, 2013

    MEMORYGEL MAMMARY PROSTHESIS

    FDA Adverse Event
    Other ·MENTOR WORLDWIDE, LLC.·Product code FTR·February 14, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·February 19, 2008

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 2, 2022

    Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

    Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    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

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018