AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MODULARIS LITHO

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OMNISENSE 7000S ULTRASOUND BONE SONOMETER

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

STREAMER POLYMER GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vitalograph Model 6600 Compact

FDA 510(k)

FDA Class 2 ·Anesthesiology

OLYMPUS CK-MB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMYLASE (ETHYLIDENE PNGPG7) KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298

FDA 510(k)

FDA Class 2 ·Neurology

Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Total Bilirubin2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVA15 insufflator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EntericBio Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

NEUROMARK System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery