TMA TEMPERATURE MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Single-Use Surgical Mask Model FE2311B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST

FDA 510(k)

FDA Class 2 ·Hematology

Medical Laser System Incanto / Evoline Platinum /Evoline

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Adani MammoScan

FDA 510(k)

FDA Class 2 ·Radiology

UNIEXPERT 2 PLUS

FDA 510(k)

FDA Class 2 ·Radiology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

FDA 510(k)

FDA Class 2 ·Dental

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054

FDA 510(k)

FDA Class 2 ·Cardiovascular

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

NEURON DELIVERY CATHETER 070

FDA 510(k)

FDA Class 2 ·Cardiovascular

COATEST PROTEIN C

FDA 510(k)

FDA Class 2 ·Hematology

Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental