BEUDAMED
    17 results · 8ms · 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 Classification: Class Ii × Status: Terminated × Clear all

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·January 18, 2017

    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

    FDA Enforcement
    Class II ·Terminated·INNOKAS MEDICAL OY·August 31, 2016

    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

    FDA Enforcement
    Class II ·Terminated·INNOKAS MEDICAL OY·February 4, 2015

    CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

    FDA Enforcement
    Class II ·Terminated·Innokas Medical Oy·November 18, 2015

    Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

    FDA Enforcement
    Class II ·Terminated·Instrumentarium Dental, PaloDEx Group Oy·March 5, 2014

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 16, 2018

    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·February 8, 2017

    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·April 19, 2017

    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·February 8, 2017

    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 9, 2018