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.
    Filters Regulation: Us FDA ×

    GYRUS ENT SOMNOPLASTY GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717100734·Gloves Nitrile Powder-Free 4.2g Large, Pkg/200

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306830297·Emesis Basin, 26.5 cm x 16 cm x 3.5 cm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155370·

    ROSA®

    FDA UDI
    Zimmer, Inc.·00889024619333·

    RADIANALYZER, MODEL 12710

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 27, 2022

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 14, 2023

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 25, 2013

    TARGET DEVICE, TIBIA

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 10, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 19, 2014

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 14, 2023

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 25, 2022

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 18, 2022

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·June 25, 2025

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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