NEUROTHERM RF CANNULA

FDA 510(k)

FDA Class 2 ·Neurology

EMBRYON GIFT TRANSFER CATHETERS/SETS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NANO-TICROWN

FDA 510(k)

FDA Class 2 ·Dental

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-ASSAY CRP (Ver.2)

FDA 510(k)

FDA Class 2 ·Immunology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·\YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES

SPECTRA HAIR REMOVAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADEPT ULTRALITE 532 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTRAGENICS ATS-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

FDA 510(k)

FDA Class 2 ·Dental

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InkSpace Imaging Small Body Array

FDA 510(k)

FDA Class 2 ·Radiology

RETCAM 3 OPHTHALMIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

TRIA HAIR REMOVAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADEPT 1064/532/755 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery