Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

XPERT MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA NASAL ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Xpert VanA Assay

FDA 510(k)

FDA Class 2 ·Microbiology

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

XPERT FLU

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA BLOOD CULTURE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dermalux Flex MD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

dermalux Flex MD

FDA 510(k)

FDA Class 2 ·Physical Medicine