NEW OUTLINE

FDA 510(k)

FDA Class 2 ·Dental

COPRA TEMP PMMA-DISK

FDA 510(k)

FDA Class 2 ·Dental

DiaTemp Flow

FDA 510(k)

FDA Class 2 ·Dental

BLOOD PRESSURE METER MODEL NO. BPM888

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXFORCE TTS SINGLE-USE BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reprocessed Compression Garments

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

FDA 510(k)

FDA Class 2 ·Radiology

10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PALINDROME RT CHRONIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALINDROME H, SI, HSI CHRONIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTRODE NEEDLES

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARTHROCARE COBLATOR IQ SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology