45 results · 39ms · Sources: EU EUDAMED, US FDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE TIGRIS VASCULAR STENT

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Ovation iX Abdominal Stent Graft System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Injectable Gel

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION 15ML SAMPLE SIZ

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)