STERILE TROCAR AND 5.7MM SLEEVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RETRACTOR

FDA 510(k)

FDA Class 2 ·Orthopedic

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1

FDA 510(k)

FDA Class 2 ·Anesthesiology

Terran NM-101

FDA 510(k)

FDA Class 2 ·Radiology

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

FDA 510(k)

FDA Class 2 ·Microbiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·UNISOL PLUS(TM) PH BALANCED SALINE SOLUTION

DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Finapres Nova Noninvasive Hemodynamic Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESYS PACS

FDA 510(k)

FDA Class 2 ·Radiology

AsoAligner

FDA 510(k)

FDA Class 2 ·Dental

TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

Terumo SurGuard 3 Safety Hypodermic Needle

FDA 510(k)

FDA Class 2 ·General Hospital

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBEEPER(R) CB-IIA

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMOTION ECG MOBILE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECG Check - Universal, ECG Check - Universal Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular