BPAP System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Home use hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Medical Surgery Mask, Model:2626-7

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AmCAD-UT Detection 2.2

FDA 510(k)

FDA Class 2 ·Radiology

IPL Salon Hair Reduction System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Temperature Module (TM0002)

FDA 510(k)

FDA Class 2 ·General Hospital

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Jimushi Sterile Urethral Catheter for single use

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AmCAD-UT

FDA 510(k)

FDA Class 2 ·Radiology

Picosecond Nd:YAG Laser Systems (BL-C10)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ERI Handheld Dental X-ray System (Model AG100)

FDA 510(k)

FDA Class 2 ·Dental

Multi-function Platform Systems (BL-M10)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Denture Base

FDA 510(k)

FDA Class 2 ·Dental

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

FDA 510(k)

FDA Class 2 ·Cardiovascular