Density

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HipCheck

FDA 510(k)

FDA Class 2 ·Radiology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Radiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

FDA 510(k)

FDA Class 2 ·Microbiology

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

RespiraSense

FDA 510(k)

FDA Class 2 ·Anesthesiology

PINNACLETM Constrained Acetabular Liners

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

C-Stem AMT LE Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

EMPHASYS Acetabular Shell with RapiTite HA

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTICUL/EZE Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA CYCLOSPORINE

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACEART OPTIMA SYSTEM SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular