BEUDAMED
    13 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.

    PATHFINDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS DIGOXIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CENTAURI/PEGASUS

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

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·June 25, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 11, 2013

    TENDRIL DX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

    AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile.

    FDA Enforcement
    Class II ·Terminated·Thayer Medical Corporation·July 11, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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