10 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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cobas e801 Immunoassay Analyzer
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code NAD·August 9, 2021
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
FDA Recall
Open, Classified
·Immunotech A.S. Radiova 1 Prague·Product code CGF·June 12, 2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGF·June 12, 2025
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
FDA Recall
Open, Classified
·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
FDA Recall
Open, Classified
·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
FDA Recall
Open, Classified
·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023
Estrone RIA, REF: DSL8700
FDA Recall
Open, Classified
·Immunotech A.S. Radiova 1 Prague·Product code CGF·December 15, 2025
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
FDA Recall
Open, Classified
·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023