Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Wearable Automated External Defibrillator

FDA classification

FDA Class 3 ·Wearable Automated External Defibrillator

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Multiple Use Blood Lancet For Multiple Patient Use

FDA classification

FDA Class 3 ·Multiple Use Blood Lancet For Multiple Patient Use

Bone Grafting Material, Dental, With Biologic Component

FDA classification

FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

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

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Processor, Cervical Cytology Slide, Automated

FDA classification

FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

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

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity™ HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter