21 results
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13ms
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Sources: EU EUDAMED, US FDA
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
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
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
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