10,000 results · 109ms · Sources: EU EUDAMED, US FDA

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Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

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

FDA Pre-Market Approval
FDA Class 3 ·ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Bausch+ Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

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

FDA Pre-Market Approval
FDA Class 3 ·DURALOC OPTION CERAMIC HIP SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2

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

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV RNA 3.0 ASSAY (BDNA)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE LEADS

FDA Pre-Market Approval
DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I

Implantable Pulse Generator, Pacemaker (Non-Crt)

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