Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SODIUM CHLORIDE TABLETS, USP

ULTRABIO

FDA 510(k)

FDA Class 2 ·Radiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 1920 WASTE GAS SCAVENGER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES

FDA 510(k)

FDA Class 2 ·Radiology

PercuNav Image Fusion and Interventional Navigation

FDA 510(k)

FDA Class 2 ·Radiology

SIGN IM NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

SIEMENS Q64XXX

FDA 510(k)

FDA Class 2 ·Radiology

K-ASSAY HS-CRP CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DENTAL PREP WASH AND PREP DISINFECT

FDA 510(k)

FDA Class 2 ·Dental

DBEST ONE-STEP HCG SERUM/URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMBULATORY EEG PLAYBACK

FDA 510(k)

FDA Class 2 ·Neurology

INSUFFLATOR CONNECTING FILTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)

FDA 510(k)

FDA Class 2 ·General Hospital