10,000 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·PRESTIGE LP CERVICAL DISC
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·LUTONIX® 035 Drug Coated Balloon PTA Catheter
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Paddle Leads
System, Esophageal Pacing
FDA Pre-Market Approval
FDA Class 3
·TAP SYSTEM 2A
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM AUSAB
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Obalon Balloon System
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS HYBRID L24 IMPLANT SYSTEM
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER
Drug-Eluting Sinus Stent
FDA Pre-Market Approval
FDA Class 3
·Propel
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate II Left Ventricular Assist System (LVAS)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Computer-Assisted Personalized Sedation System
FDA Pre-Market Approval
FDA Class 3
·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT
FDA Pre-Market Approval
PURE-DENT B851 ABSORBABLE DUSTING POWDER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM