4,523 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Assay, Antibody, Folr1
FDA Pre-Market Approval
FDA Class 3
·VENTANA FOLR1 (FOLR-2.1) RxDx Assay
Immunohistochemistry Assay, Antibody, Folr1
FDA Pre-Market Approval
FDA Class 3
·VENTANA FOLR1 (FOLR-2.1) RxDx Assay
Immunohistochemistry Assay, Antibody, Folr1
FDA Pre-Market Approval
FDA Class 3
·VENTANA FOLR1 (FOLR-2.1) RxDx Assay
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia)
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G System with SmartGuard
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MIRCO-DRIVER OVER-THE -WIRE(OTW) CORONARY STENT SYSTEM & MX2 CORONARY STENT SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M)
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Epsila EV Extravascular Lead (EV2401)
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
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Sculptra, Sculptra Aesthetic
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILITATION SYSTEM
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILITATION SYSTEM