BALLOON ELECTROSURGICAL PROBES AND DEVICES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Laparoscopic Handles with peek Insulation

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASPIRE COVERED STENT AND DELIVERY CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FACSORT FLOW CYTOMETER

FDA 510(k)

FDA Class 2 ·Hematology

NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS

FDA 510(k)

FDA Class 2 ·Radiology

LASERSCOPE EL LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDI-TECH BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUIDER-22

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)

FDA 510(k)

FDA Class 2 ·Hematology

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

FDA 510(k)

FDA Class 2 ·Neurology

BLAZER DX-20 DIAGNOSTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONSTELLATION CATHETERS, MODEL 8039

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERDOC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tablo Hemodialysis System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery