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

POLY INSERT 20 DEGREE

FDA 510(k)
FDA Class 3 ·Orthopedic

POROUS-COATED TITANIUM ACETABULAR CUP

FDA 510(k)
FDA Class 3 ·Orthopedic

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Isoflex Low Voltage Lead

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE, RADIESSE LOW VISCOSITY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE LOW VISCOSITY, RADIESSE (+)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Isoflex Low Voltage Leads

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·DURAFLEX LOW PRESSURE BIOPROSTHESIS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·IsoFlex Low Voltage Passive

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDA-MV PACING SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA