ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYLINDER OF GAS, CAN OF GAS (CC12F2)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Spectra Cashmere

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AIC disposable medical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO 4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Spectra S3 Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Fetal Doppler, Model FD88

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SOLCO 4CIS GENERAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Spectra 9Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Hexa-Temp

FDA 510(k)

FDA Class 2 ·Dental

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EsCem

FDA 510(k)

FDA Class 2 ·Dental

4CIS SOLAR AND APOLLON SPINE SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile Lancets for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery