1,657 results · 21ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BTF/BJF - STELIX II BRF

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA 2, RHA 3, RHA 4

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA®3 dermal filler

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS (R) Total Knee System

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM