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

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Aspire Cristalle Digital Breast Tomosynthesis Option

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13 C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, Viva CRT-P

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MICRA TRANSCATHETER PACEMAKER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI SURESCAN IPG