803 results · 22ms · Sources: EU EUDAMED, US FDA

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex™ 0.035” OTW Drug-Coated Angioplasty Balloon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Ballon

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·BAROSTIM NEO® System

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·Barostim™ System Heart Failure

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·Barostim™ System

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·Barostim NEO System, Barostim NEO2 System

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·BAROSTIM NEO® System

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·ESOPHAGEAL PACING SYSTEM

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si