92 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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All-in-One Health Monitor, PC-303
FDA 510(k)
FDA Class 2
·Cardiovascular
Contour+ (MVision AI Segmentation)
FDA 510(k)
FDA Class 2
·Radiology
MVision AI Segmentation
FDA 510(k)
FDA Class 2
·Radiology
CRE RX Biliary Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
FDA 510(k)
FDA Class 2
·General Hospital
Safe Secure Sterilization Pouches and Rolls
FDA 510(k)
FDA Class 2
·General Hospital
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
FDA 510(k)
FDA Class 2
·Radiology
Handheld Pulse Oximeter, Model SP-20
FDA 510(k)
FDA Class 2
·Cardiovascular
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
FDA 510(k)
FDA Class 2
·Dental
MANTIS Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CO2 Laser Machine, Model: BW-203B
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode Laser Machine, Model Number: BM-100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
FDA 510(k)
FDA Class 2
·Radiology
Balloon Inflation System
FDA 510(k)
FDA Class 2
·Orthopedic
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
GEHC DXA Bone Densitometers with enCORE version 18
FDA 510(k)
FDA Class 2
·Radiology
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
FDA 510(k)
FDA Class 2
·Radiology
GE Lunar DXA Bone Densitometers with enCORE version 17
FDA 510(k)
FDA Class 2
·Radiology
IPL Hair Removal Device (BE965A, BE965B, BE965C)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery