Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VenaSeal Closure System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL 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 AmpliPrep/COBAS TaqMan HCV Test, v2.0

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL(R) MATRIX/PROCEED(TM) HEMOSTATIC SEALANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas KRAS Mutation Test

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·16F LASER SHEATH ENHANCEMENT MODEL#500-013

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 SERIES INFLATABLE PENILE PROSTHESES

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC NEUROSTIMULATION SYSTEMS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test, V2.0