MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

FDA 510(k)

FDA Class 2 ·Radiology

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

RI MSC (MIGRATION SEDIMENTATION CHAMBER)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E1000 Dx Digital Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

SATURN ACTIVE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RI Witness Embryology Heated Plate

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSTEOTEC SILICONE FINGER IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOVIEW

FDA 510(k)

FDA Class 2 ·Radiology

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

Panpac Flexi Shelf Pessary

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PANPAC VAGINAL DILATORS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Panpac Disposable Pessary Fitting Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)