HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

NAVSTATIONIRAD EMT, VERSION 1.1

FDA 510(k)

FDA Class 2 ·Radiology

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

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

FDA 510(k)

FDA Class 2 ·Dental