11 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·July 16, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
FDA Recall
Open, Classified
·Pentax of America Inc·Product code PEA·January 29, 2025
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023
Pink Luminous Breast, Breast transilluminator
FDA Recall
Open, Classified
·Silkprousa LLC·Product code LEK·May 20, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021