ENTERPRISE ELECTROPHYSIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

EVIDENCE BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)

FDA 510(k)

FDA Class 2 ·Neurology

FLUOROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OsteoSelect PLUS Demineralized Bone Matrix Putty

FDA 510(k)

FDA Class 2 ·Orthopedic

RE-USABLE STERILIZATION POUCH / BAG

FDA 510(k)

FDA Class 2 ·General Hospital

DURA-PATCH MODEL DP-XXX

FDA 510(k)

FDA Class 2 ·Neurology

EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

PROLITE III TOWER AND PR AND HR HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-spine Cortical Bone Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cortera™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VIRILIS PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILICONE ELASTOMER SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO FLUOROTEX II SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Radioimmunoassay, Cyclic Gmp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry