Hygenix

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO

FDA 510(k)

FDA Class 2 ·Radiology

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

Global Shoulder and Delta CTA systems

FDA 510(k)

FDA Class 2 ·Orthopedic