Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT,

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR XTS PHOTOPHERESIS SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·LEAD KIT FOR DEEP BRAIN STIMULATION/QUADRIPOLAR EXTENSION KIT FOR DEEP BRAIN STIMULATION

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2/SERVICE KIT-PACEMAKER REPAIR KIT/VITATRON BRILLLIANT S+ VDD LEAD

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV RNA QUALITATIVE ASSAY

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

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

FDA Pre-Market Approval

FDA Class 2 ·Roche cobas HCV

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·xT CDx

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 22 Cochlear Implant System

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·(QON) InterStim® Therapy System, Verify® Evaluation System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LVAS