PLANER BT37 INCUBATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

P200T

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTOS OCT/SLO MICROPERIMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

DAYTONA ICG (P200TICG)

FDA 510(k)

FDA Class 2 ·Ophthalmic

P200DTx

FDA 510(k)

FDA Class 2 ·Ophthalmic

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

SKYLARK MODEL 1001 TENS DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

SKYLARK GB 1000

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA BALLOON DILATATION CATHETERS

SmartTarget

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON DEVICE

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