FDA.reportPublic FDA data

Heart valve annulus sizer, reusable

Definition
A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.
GUDID devices
216
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00690103019421HEART VALVE ACCESSORY OBTURATOR FOR MITRAL XENOGRAFT 25MMEdwards Lifesciences LLC11622026-04-03
00690103019438HEART VALVE ACCESSORY OBTURATOR FOR MITRALXENOGRAFT 27MMEdwards Lifesciences LLC11622026-04-03
00690103019445HEART VALVE ACCESSORY OBTURATOR FOR MITRAL XENOGRAFT 29MMEdwards Lifesciences LLC11622026-04-03
00690103019452HEART VALVE ACCESSORY OBTURATOR FOR MITRAL XENOGRAFT 31MMEdwards Lifesciences LLC11622026-04-03
00690103019469HEART VALVE ACCESSORY OBTURATOR FOR MITRAL XENOGRAFT 33MMEdwards Lifesciences LLC11622026-04-03
00690103019476OBTURATOR FOR MITRAL XENOGRAFT 35MMEdwards Lifesciences LLC11622026-04-03
00690103019643HEART VALVE ACCESSORYEdwards Lifesciences LLC11702026-04-06
00690103019650HEART VALVE ACCESSORYEdwards Lifesciences LLC11702026-04-06
00690103019674HEART VALVE ACCESSORYEdwards Lifesciences LLC11702026-04-06
00690103019698HEART VALVE ACCESSORYEdwards Lifesciences LLC11702026-04-06
00690103019704HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019711HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019742HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019759HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019780HEART VALVE ACCESSORYEdwards Lifesciences LLC1174M2026-04-06
00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019858HEART VALVE ACCESSORYEdwards Lifesciences LLC1175T2026-04-06
00690103019889KONECT AVC SIZER 19MMEdwards Lifesciences LLC11902026-04-06
00690103019896KONECT AVC SIZER 21MMEdwards Lifesciences LLC11902026-04-06
00690103019902KONECT AVC SIZER 23MMEdwards Lifesciences LLC11902026-04-06
00690103019919KONECT AVC SIZER 25MMEdwards Lifesciences LLC11902026-04-06
00690103019926KONECT AVC SIZER 27MMEdwards Lifesciences LLC11902026-04-06
00690103167276HEART VALVE ACCESSOREdwards Lifesciences LLC1169HP2026-04-03
00690103167283HEART VALVE ACCESSORYEdwards Lifesciences LLC1169HP2026-04-03
00690103167290HEART VALVE SIZER ACCESSORYEdwards Lifesciences LLC1169HP2026-04-03
00690103167306HEART VALVE ACCESSORYEdwards Lifesciences LLC1169HP2026-04-03
00690103167313HEART VALVE ACCESSORYEdwards Lifesciences LLC1169HP2026-04-03
00690103174878HEART VALVE ACCESSORYEdwards Lifesciences LLC1169P2026-04-03
00690103174885HEART VALVE ACCESSORYEdwards Lifesciences LLC1169P2026-04-03
00690103174892HEART VALVE ACCESSORYEdwards Lifesciences LLC1169P2026-04-03
00690103174908HEART VALVE ACCESSORYEdwards Lifesciences LLC1169P2026-04-03
00690103174915HEART VALVE ACCESSORYEdwards Lifesciences LLC1169P2026-04-03
00690103185683SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185690SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185706SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185713SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185720SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185737SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185744SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185751SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103185768SIZER FOR MODEL 5200 PHYSIO II RINGEdwards Lifesciences LLC12522026-04-06
00690103187915PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187922PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187939PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187946PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187953PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187960PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103187977PHYSIO TRICUSPID SIZEREdwards Lifesciences LLC12622026-04-06
00690103188318CARPENTIER-EDWARDS SAV 19MM SIZING INSTRUMENTSEdwards Lifesciences LLC11662026-04-03
00690103188325XENOGRAFTEdwards Lifesciences LLC11662026-04-03
00690103188332XENOGRAFTEdwards Lifesciences LLC11662026-04-03
00690103188349XENOGRAFTEdwards Lifesciences LLC11662026-04-03
00690103188356XENOGRAFTEdwards Lifesciences LLC11662026-04-03
00690103188363CARPENTIER-EDWARDS SAV 29MM SIZING INSTRUMENTSEdwards Lifesciences LLC11662026-04-03
00690103188370CARPENTIER-EDWARDS SAV 31MM SIZING INSTRUMENTSEdwards Lifesciences LLC11662026-04-03
00690103190496EDWARDS INTUITY SIZEREdwards Lifesciences LLC1183VSA192026-04-06
00690103190502EDWARDS INTUITY SIZEREdwards Lifesciences LLC1183VSA212026-04-06
00690103190519EDWARDS INTUITY SIZEREdwards Lifesciences LLC1183VSA232026-04-06
00690103190526EDWARDS INTUITY SIZEREdwards Lifesciences LLC1183VSA252026-04-06
00690103190533EDWARDS INTUITY SIZEREdwards Lifesciences LLC1183VSA272026-04-06
00690103200225EDWARDS INTUITY ELITE AORTIC SIZER 19Edwards Lifesciences LLC1183R2026-04-06
00690103200232EDWARDS INTUITY ELITE AORTIC SIZER 21Edwards Lifesciences LLC1183R2026-04-06
00690103200249EDWARDS INTUITY ELITE AORTIC SIZER 23Edwards Lifesciences LLC1183R2026-04-06
00690103200256EDWARDS INTUITY ELITE AORTIC SIZER 25Edwards Lifesciences LLC1183R2026-04-06
00690103200263EDWARDS INTUITY ELITE AORTIC SIZER 27Edwards Lifesciences LLC1183R2026-04-06
00690103200270EDWARDS INTUITY ELITE AORTIC SIZER 29Edwards Lifesciences LLC1183R2026-04-06
00690103201352KONECT AVC SIZER 29MMEdwards Lifesciences LLC11902026-04-06
00763000990657Mosaic Neo™ S310MNHMEDTRONIC, INC.S310MNH2026-04-13
00763000990664Mosaic Neo™ S310MNSMEDTRONIC, INC.S310MNS2026-04-13
05415067042354Regent™ST. JUDE MEDICAL, INC.9072023-02-17
B040ASR23250Annular Sizer AorticGENESEE BIOMEDICAL, INC.ASR23/252024-12-05