Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid L24 Implant System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Lung System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minitouch 3.8 Era System (Minitouch System)