Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

SMOKE EVACUATION ATTACHEMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INF 4160, MODEL D-FJ27F

FDA 510(k)

FDA Class 2 ·Neurology

QIZHOU ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A

FDA 510(k)

FDA Class 2 ·Anesthesiology

LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Azure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rapid Barostat Bag (RBB) Pump and Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SilverCoat Silicone Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PatCom Distal Chip Endoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Garment Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Conductive Gel

FDA 510(k)

FDA Class 2 ·Neurology

TONE-A-MATIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

PatCom Single-Use Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRESSURIZED INFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SERUM TRANSPORT VIALS, T25/SC, TZ10/SC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology