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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·SWEDISH ADJUSTABLE GASTRIC BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND