GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH

FDA 510(k)

FDA Class 2 ·Dental

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

FluChip-8G Influenza A+B Assay

FDA 510(k)

FDA Class 2 ·Microbiology

REAADS PROTEIN S ANTIGEN TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

BABY FACE

FDA 510(k)

FDA Class 2 ·Radiology

AZTECH 70

FDA 510(k)

FDA Class 2 ·Dental

SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Polaris Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

STEALTHSTATION SYSTEM DIGITIZER CHANGE

FDA 510(k)

FDA Class 2 ·Neurology

BA310 Abutment, BIA310 Implant/Abutment

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TightRail Sub-C Rotating Dilator Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE

FDA 510(k)

FDA Class 2 ·Dental

LANX CERVICAL SA

FDA 510(k)

FDA Class 2 ·Orthopedic

ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic