Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ADANTE PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC NINJA PTCA DILATATION CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Low Dead Space Needle, Single Lumen, Hypodermic

FDA classification

FDA Class 2 ·Low Dead Space Needle, Single Lumen, Hypodermic

Dislodger, Stone, Flexible, Ureteral, Reprocessed

FDA classification

FDA Class 2 ·Dislodger, Stone, Flexible, Ureteral, Reprocessed

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification

FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

FDA classification

FDA Class 2 ·Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Dental Abutment Design Software For Dental Laboratory

FDA classification

FDA Class 2 ·Dental Abutment Design Software For Dental Laboratory

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Cardiovascular Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

FDA classification

FDA Class 2 ·Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER MX2 BALLOON DILATATION CATHETER