13 results · 11ms · Sources: EU EUDAMED, US FDA

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Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

FDA classification
FDA Class 2 ·Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

SMARTBUILDER SYSTEM (SB1)

FDA 510(k)
FDA Class 2 ·Dental

Speedboat Flush SB1 Instrument

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

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

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

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

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

ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30

FDA 510(k)
FDA Class 2 ·Cardiovascular

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

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

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

FDA classification
FDA Class 2 ·Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Trocar, Gastro-Urology

FDA classification
FDA Class 2 ·Trocar, Gastro-Urology