19 results · 20ms · Sources: EU EUDAMED, US FDA

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·FEMCAP

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·NOVOTTF-100A SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE