BEUDAMED
    15 results · 19ms · 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 ×

    ATAC PAK ALP REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102763·Astra®-compatible Lilac 4.5/5.0mm 30° Multi-Uni...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161075428·GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL p...

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470022851·GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL p...

    ULTRASOUND SCANNER, TYPE 1101

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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

    HUDSON AQUAPAK HUMIDIFIER ADAPTOR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·January 26, 2011

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.,·Product code MHY·February 22, 2008

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 6, 2022

    Colonoscope, Model Number CF-H180AL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020