32 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SERATEST RF (HEMAGGLUTINATION) KIT
FDA 510(k)
FDA Class 2
·Immunology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128830·Revision Fluted Stem 22mm x 100mm
AlphaVent
FDA UDI
STRYKER CORPORATION·07613327599510·ALPHAVENT SUTURE ANCHOR 5.5MM BIOCOMPOSITE, SUT...
ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM
FDA 510(k)
FDA Class 1
·Hematology
SATLEC PROPHY UNIT PU 3055
FDA 510(k)
FDA Class 2
·Dental
CAPSUREEPI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 6, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 3, 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 Recall
Open, Classified
·Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China·Product code JAK·May 23, 2020
uCT 760 System, Computed Tomography X-ray System
FDA Recall
Terminated
·Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China·Product code JAK·May 8, 2020
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
FDA Recall
Terminated
·Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China·Product code KPR·July 30, 2019
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Recall
Terminated
·Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China·Product code KPS·August 26, 2019
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025