Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

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)

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

Penile Implant Surgical Accessories

FDA classification

FDA Class 1 ·Penile Implant Surgical Accessories

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

FDA classification

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

Light Source System, Diagnostic Endoscopic

FDA classification

FDA Class 3 ·Light Source System, Diagnostic Endoscopic

Low Dead Space Needle, Single Lumen, Hypodermic

FDA classification

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

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

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

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

Prostate Immobilizer Rectal Balloon

FDA classification

FDA Class 2 ·Prostate Immobilizer Rectal Balloon

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

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device