DUAL GUIDE INTRODUCER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS ULTRA-1 THROMBOPLASTIN

FDA 510(k)

FDA Class 2 ·Hematology

PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CAPCARD

FDA 510(k)

FDA Class 2 ·General Hospital

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Redi-Spine

FDA 510(k)

FDA Class 2 ·Orthopedic

HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

KESTREL LENS CASE 1543-893S/P-1700-2611

FDA 510(k)

FDA Class 2 ·Ophthalmic

Biodesign Otologic Repair Graft

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

3I CALCIUM SULFATE BONE CEMENT

FDA 510(k)

FDA Class 2 ·Dental

OsteoSync™ Ti Dental Mesh

FDA 510(k)

FDA Class 2 ·Dental

ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Endovascular Dilator and Sets

FDA 510(k)

FDA Class 2 ·Cardiovascular

Orthex External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Taperloc® Complete Hip Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

IBOND GLUMA INSIDE

FDA 510(k)

FDA Class 2 ·Dental

AMPHETAMINES II ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP

FDA 510(k)

FDA Class 2 ·Orthopedic

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CEMENTED FEMORAL HEAD RESURFING DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic