L1-PRO SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT CONVENIENCE PACK: DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

VariSeed 9.0

FDA 510(k)

FDA Class 2 ·Radiology

VARIAN NASOPHARYNX APPLICATOR

FDA 510(k)

FDA Class 2 ·Radiology

COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT D.A.U. PROPOXYPHENE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eclipse Treatment Planning System

FDA 510(k)

FDA Class 2 ·Radiology

TRILOGY RADIOTHERAPY DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMIT VALPROIC ACID ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Esophagus Bougie Set

FDA 510(k)

FDA Class 2 ·Radiology

COHERENT XA-40 CO2 SURGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)

FDA 510(k)

FDA Class 2 ·Dental

NIDEK ADC-8000 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

ON-BOARD IMAGER DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO:HEALTH BUDDY APPLIANCE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)

FDA 510(k)

FDA Class 2 ·General Hospital