Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

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

FDA Pre-Market Approval

FDA Class 3 ·TruSight Oncology Comprehensive

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Stent, Coronary

FDA classification

FDA Class 3 ·Stent, Coronary

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS DR-T AND LUMOS VR-T

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

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

FDA Pre-Market Approval

FDA Class 3 ·xT CDx

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II DR-T

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV-T

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4