Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

DRY LASER IMAGER, MODEL DRYPRO MODEL 793

FDA 510(k)

FDA Class 2 ·Radiology

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

FDA 510(k)

FDA Class 2 ·Radiology

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

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology