3,600 results · 32ms · Sources: EU EUDAMED, US FDA

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF IMPLANTABLE SPINAL FUSION STIMULATORS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT HBE (RDNA) EIA

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx DownStream System

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx Downstream System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·OBALON BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon Kit

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·Liposorber LA-15 System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 System

Lipoprotein, Low Density, Removal

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

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval
FDA Class 3 ·SLEEP SENTRY(TM)