Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS

IRIS Pi Q switched Nd YAG laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED WAVE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEAP EXPRESS PLUSS

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OXYGEN MEDICELS, CITICELS

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PYRAMIDION Dental Implants and Prostheses

FDA 510(k)

FDA Class 2 ·Dental

SILK'N

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLASH N' GO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILK'N FLASH N GO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FEP RINGED GORE-TEX VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Comaneci, Comaneci Petit, Comaneci 17

FDA 510(k)

FDA Class 2 ·Neurology

FRACTORA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Geneo X Elite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular