AssureTech Panel Dip Test, AssureTech Quick Cup Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROSOFT

FDA 510(k)

FDA Class 2 ·Dental

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Wondfo T-Cup Multi-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VISENSIA, VISENSIA WITH ALERT

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

GRAFTSITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANCHORMAN Tibial Ligament Fixation Device

FDA 510(k)

FDA Class 2 ·Orthopedic

VFSS IMAGER, MODEL SIS-300

FDA 510(k)

FDA Class 2 ·Radiology

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)

FDA 510(k)

FDA Class 2 ·Neurology

ThermaCare Quick Therapy TENS

FDA 510(k)

FDA Class 2 ·Neurology

5000Z SYSTEM (OTC)

FDA 510(k)

FDA Class 2 ·Neurology

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

FDA 510(k)

FDA Class 2 ·Neurology

Tyece OTC TENS Device

FDA 510(k)

FDA Class 2 ·Neurology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology