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Sources: EU EUDAMED, US FDA
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Inherited Nucleotide Repeat Disorder Dna Test
FDA classification
FDA Class 2
·Inherited Nucleotide Repeat Disorder Dna Test
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
FUKUDA DENSHI
FDA UDI
FUKUDA DENSHI CO.,LTD.·04538612912351·
Aria Hybrid Valve
FDA UDI
CYPRESS ADAPTIVE, LLC·00850013242085·Aria Hybrid valve auto expulsion suction valve ...
LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DAIG TYPE O4 VS-1 CONNECTOR
FDA 510(k)
FDA Class 3
·Cardiovascular
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780033974·OSV II® Valve System WITH ANTECHAMBER AND INTEG...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034025·OSV II® Lumbar Valve System
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034056·Valve System WITH ANTECHAMBER, SEPARATE 15 CM V...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034087·OSV II® Valve System WITH INTEGRAL 7CM VENTRICU...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780033981·OSV II® Valve System WITH ANTECHAMBER AND INTEG...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780035459·OSV II® Low Pro Valve Unit WITH ANTECHAMBER AND...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780036074·OSV II® Valve System 2 PIECE SYSTEM WITH ANTECH...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780035480·OSV II® Valve System
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780033998·Valve System WITH ANTECHAMBER FLOW REGULATION* ...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034032·OSV II® Valve System WITH ANTECHAMBER AND SEPAR...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780033929·OSV II® Valve Unit WITH ANTECHAMBER AND 2 INTEG...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034070·OSV II® Valve System WITH ANTECHAMBER AND INTEG...
OSV II®
FDA UDI
Integra LifeSciences Switzerland Sàrl·10381780034049·OSV II® Valve System WITH SEPARATE 15CM VENTRIC...