85 results · 22ms · Sources: EU EUDAMED, US FDA

GI Genius

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ME-APDS™; MAGENTIQ-COLO™

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT Software

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EW10-EC02 Endoscopy Support Program

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAGENTIQ-COLO (ME-APDS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EndoScreener

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CADDIE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Gastrointesinal Lesion Software Detection System

FDA classification
FDA Class 2 ·Gastrointesinal Lesion Software Detection System

ARTHREX TENODESIS FAMILY

FDA 510(k)
FDA Class 2 ·Orthopedic

ARGESOL PNP

FDA 510(k)
FDA Class 2 ·Dental

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

FDA 510(k)
FDA Class 2 ·Hematology

BIOTRONIK DNP UNIPOLAR

FDA 510(k)
FDA Class 2 ·Cardiovascular