Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon PTA Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV assay

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

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HR HPV

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM ABORBABLE GELATIN SPONGE

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime HBV

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 ASSAY

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER® LA-15 System

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP),

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

FDA Pre-Market Approval

FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·ORCEL BILAYERED CELLULAR MATRIX

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit