Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Procedural Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB / Alinity i Anti-HBs

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II INFUSION PUMP

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA / Alinity i Total PSA

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval

FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY® Anti-c-KIT (9.7) Primary Antibody

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit.

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

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

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE