Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

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

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·RealTime IDH1

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·RealTime IDH2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·HER2 Dual ISH DNA Probe Cocktail

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000

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