3,927 results · 19ms · Sources: EU EUDAMED, US FDA

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELLAFILL

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System with SmartGuard

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·ExAblate

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity™

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·UROLUME(R) ENDOPROSTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Radiesse (+) Injectable Implant

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·CyPass Ultra System