The GIRO Growth Modulation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

The Simple Locking IntraMedullary (SLIM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

GAP ENDO-EXO MEDULLARY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Y3 Proximal Femoral Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CROSS SAIL CORONARY DILATATION CATHETER

Orthopedic Stereotaxic Instrument

FDA classification

FDA Class 2 ·Orthopedic Stereotaxic Instrument

GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONOLITH I-MOVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDIGUIDE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIPOSONIX SYSTEM, MODEL 1 P00XXXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHALLENGE 6010 POWERED MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

THE SELBY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CYANODONT DENTAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

FDA 510(k)

FDA Class 2 ·Orthopedic

TOSOH AIA-PACK T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POWERED INFLATABLE TUBE MASSAGER, SPORT-MED

FDA 510(k)

FDA Class 2 ·Physical Medicine