36 results · 20ms · Sources: EU EUDAMED, US FDA

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-19 ADAPTAID ADAPTER SLEEVE

FDA 510(k)
FDA Class 3 ·Cardiovascular

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular

POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular