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

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (6F)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (6F)

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (6F)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 CGM System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE & MICROFIBRILLAR FORM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System