82 results
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25ms
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Sources: EU EUDAMED, US FDA
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Country: China
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ISA MOULD ENGINEERING LIMTED
FDA registration
ISA MOULD ENGINEERING LIMTED·4 products·🇨🇳 China
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
FDA Enforcement
Class II
·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
FDA Enforcement
Class II
·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
FDA Enforcement
Class II
·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
FDA Enforcement
Class II
·Terminated·Getinge (Suzhou) Co Ltd·June 9, 2021
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·May 1, 2013
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·March 10, 2021
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 29, 2020
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·May 1, 2013
GE Carestation 30 anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
GE 9100c NXT anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
XIAMEN ASA SUNGLASSES CO., LTD.
FDA registration
XIAMEN ASA SUNGLASSES CO., LTD.·1 product·🇨🇳 China
Wuhan MGI Tech Co., Ltd.
Manufacturer
🇨🇳 China·3 Importers
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·October 11, 2023
NATEEN ADULT DIAPER
Device
EU MDR
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Eu Md Class 1
·FUJIAN DASHAN PAPER CO.,LTD·On the market
NATEEN ADULT DIAPER
Device
EU MDR
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Eu Md Class 1
·FUJIAN DASHAN PAPER CO.,LTD·On the market
NATEEN ADULT DIAPER
Device
EU MDR
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Eu Md Class 1
·FUJIAN DASHAN PAPER CO.,LTD·On the market