21 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 14, 2015
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·August 7, 2019
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·April 20, 2016
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
FDA Enforcement
Class III
·Terminated·Biocare Medical, LLC·June 3, 2015
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
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Enforcement
Class III
·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018
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