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

FDA Pre-Market Approval

FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITIORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDxBRCA

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·OneTouch Vibe™ Plus System

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT TB TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS KRAS MUTATION TEST