TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

Belun Sleep System BLS-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

SmileAlign Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Choledochoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DailyMate Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

SaviSafe Safety Device

FDA 510(k)

FDA Class 2 ·General Hospital

BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Dexus Prosthetics System (Model: MSL1, MSR1)

FDA 510(k)

FDA Class 2 ·Neurology

ORION Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pusen Eview Medical Video Endoscope Image Processor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MissLan™ Digital Pregnancy Rapid Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AccuBrain

FDA 510(k)

FDA Class 2 ·Radiology

Sinobot X1

FDA 510(k)

FDA Class 2 ·Neurology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)