IMMULITE 2000 SPECIFIC ALLERGENS

FDA 510(k)

FDA Class 2 ·Immunology

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

FDA 510(k)

FDA Class 2 ·Radiology

MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

X-View 3D Pan/X-View 2D Pan

FDA 510(k)

FDA Class 2 ·Radiology

MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Cooling Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Cooling Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Galvanic Spa, Model: SKB-1405

FDA 510(k)

FDA Class 2 ·Neurology

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

FDA 510(k)

FDA Class 2 ·Neurology

IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0

FDA 510(k)

FDA Class 2 ·Radiology

MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D

FDA 510(k)

FDA Class 2 ·Cardiovascular

NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RespiraSense

FDA 510(k)

FDA Class 2 ·Anesthesiology

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology