BEUDAMED
    18 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·September 14, 2016

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 20, 2013

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 17, 2016

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·April 26, 2017

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·October 21, 2020

    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