Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON DEVICE

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Rocket Platinum Cured Cathter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRODOSE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPTIAM SYPHILIS-G ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOMETRIAL SAMPLING SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONICAID MODEL P110 FETAL HEAR DETECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PORTLAND TROCARS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SONICAID MODEL TEAM FECG IUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SYNERGY LT

FDA 510(k)

FDA Class 2 ·Neurology

MEDILOG MR95

FDA 510(k)

FDA Class 2 ·Neurology

SURGICAL RETRACTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology