565 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBC IGM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Percept Deep Brain Stimulation Therapy System
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Vanta Spinal Cord Stimulation Systems
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Catheter, Sampling, Chorionic Villus
FDA Pre-Market Approval
FDA Class 3
·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
FDA Pre-Market Approval
FDA Class 3
·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
FDA Pre-Market Approval
FDA Class 3
·ALERT SYSTEM-COMPANION II
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Simplify Disc
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Simplify® Cervical Artificial Disc