BEUDAMED
    17 results · 17ms · 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.

    0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICRO-MEDIA MICRODILUTION TEST PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Knee+

    FDA 510(k)
    FDA Class 2 ·Neurology

    D901 LILLIPUT OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·October 13, 2021

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·February 10, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 23, 2014

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011

    CER BIOLOXD OPTION HD 40MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·June 26, 2019

    CUSTOM PERFUSION PACK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012

    BIOLOX DELTA CER OPTION HD 36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·July 14, 2025

    LILLIPUT 1 START

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 17, 2023

    LILLIPUT 1 OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code DTZ·December 27, 2024

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·December 6, 2024

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·January 17, 2022

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·January 25, 2022

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022