1,822 results · 20ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

Wearable Automated External Defibrillator

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SYNTHES PRODISC-L TOTAL DISC REPLACEMENT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc C Total Disc Replacement

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·VITREON(R)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest® Wearable Defibrillator

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VIEWPOINT CK SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION EXCIMER LASER SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA AESTHETIC

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay