565 results · 28ms · Sources: EU EUDAMED, US FDA

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