CONFORMIS UNI-CONDYLAR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Dental

JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)

FDA 510(k)

FDA Class 2 ·Dental

EM ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

UGYTEX MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Catheter, Hemodialysis, Triple Lumen, Implanted

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Triple Lumen, Implanted

Pump, Infusion, Insulin Bolus

FDA classification

FDA Class 2 ·Pump, Infusion, Insulin Bolus

Midline Catheter

FDA classification

FDA Class 2 ·Midline Catheter

Temporary Tissue Marker

FDA classification

FDA Class 2 ·Temporary Tissue Marker

Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA classification

FDA Class 2 ·Electrode, Pacing And Cardioversion, Temporary, Epicardial

Central Venous Catheter With Manual Insertion System

FDA classification

FDA Class 2 ·Central Venous Catheter With Manual Insertion System

Camera, Ophthalmic, Non-Prescription

FDA classification

FDA Class 2 ·Camera, Ophthalmic, Non-Prescription

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification

FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

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 CMV