211 results · 21ms · Sources: EU EUDAMED, US FDA

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX Reflux Management System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Synergy Ablation System

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·Linx Reflux Management System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur Anti-HBe2 (aHBe2) assay

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS