HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Talis EMR with Talis +ACG (Talis EMR with +ACG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET

FDA 510(k)

FDA Class 2 ·General Hospital

ACG-8511 PORTABLE ECG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TSolution One w/ACG surgical System

FDA 510(k)

FDA Class 2 ·Neurology

Sherlock 3CG+ T ip Confirmation System

FDA 510(k)

FDA Class 2 ·General Hospital

Sherlock 3CG Tip Positioning System Stylet

FDA 510(k)

FDA Class 2 ·General Hospital

Sherlock 3CG Tip Positioning System Stylet

FDA 510(k)

FDA Class 2 ·General Hospital

TSolution One w/ACG+ Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

FDA 510(k)

FDA Class 2 ·General Hospital

THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

FDA 510(k)

FDA Class 2 ·General Hospital

CLINITEK MICROALBUMIN REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)

PES HOT/COLD COMPRESS

FDA 510(k)

FDA Class 2 ·Physical Medicine

SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOVINE PERICARDIUM PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

FDA 510(k)

FDA Class 2 ·General Hospital