BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    HEARTSTREAM FR2 AED, MODEL M3860A,M3861A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Premier Explorers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783006223·Explorer DE_PA 6/23

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085021652·Auramine O Rhodamine B Stain Set

    Arrigo Professional Supplies LLC

    FDA UDI
    ARRIGO PROFESSIONAL SUPPLIES LLC·00850072625034·Self Sealing Sterilization Pouch,3.5" x 6.5" (3...

    HEARTSTREAM FR2 WITH AN ECG CABLE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code DPS·March 14, 2012

    STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    IQ200

    FDA Adverse Event
    Malfunction ·IRIS INTERNATIONAL·Product code KQO·July 2, 2015

    HANDLE BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·July 11, 2024

    GEL-FILL MAMMARY IMPLANT, 260 CC

    FDA Adverse Event
    MCGHAN MEDICAL CORP.·Product code FTR·October 3, 1994

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 11, 2013

    SUBDURAL TUNNELING ICP MONITORING KIT

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES SD·Product code GWM·February 22, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 25, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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