BEUDAMED
    12 results · 20ms · 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 ×

    SPIROBANK II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FITLIFE

    FDA UDI
    Respironics, Inc.·00606959023062·FitLife Mask with Headgear, with Standard Elbow...

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788020321·RX Epidural Needle 12g TW x 7.0"

    LATEX EXAMINATION GLOVES- POWDER FREE, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    3D ACTIVETRAC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013

    BUBBLE CPAP CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·June 17, 2008

    BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 24, 2019

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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