EDEN Spinal Fixation MIS System

FDA 510(k)

FDA Class 2 ·Orthopedic

QUASAR Standalone ACIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

S-Patch (S-Patch ExL)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MISTI Silicone Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hair Up

FDA 510(k)

FDA Class 2 ·Physical Medicine

MegaGen Dental Implant Abutment

FDA 510(k)

FDA Class 2 ·Dental

Mega Plus Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

WillCeph

FDA 510(k)

FDA Class 2 ·Radiology

Smart Kit Basic, Smart Kit Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALLAS 308/311 Solid-State UV Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I RUNE (I-200L)

FDA 510(k)

FDA Class 2 ·Neurology

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

5D Viewer

FDA 510(k)

FDA Class 2 ·Radiology

VINT

FDA 510(k)

FDA Class 2 ·Radiology

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4

FDA 510(k)

FDA Class 2 ·Dental

Omega VL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEON-C Stand Alone System

FDA 510(k)

FDA Class 2 ·Orthopedic

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUXEN Zr, LUXEN Smile

FDA 510(k)

FDA Class 2 ·Dental