Dental Impression Material

FDA 510(k)

FDA Class 2 ·Dental

Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound

FDA 510(k)

FDA Class 2 ·Radiology

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Distal Access Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Beauty LED Mask, Model: KFB265

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

5MP GRAYSCALE LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

FDA 510(k)

FDA Class 2 ·Neurology

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Endoscopic Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST