Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Ring, Annuloplasty

FDA product code KRH · 74 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3800
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-26 – 2026-06-18

KRH 2026-06-18

MEMO 4D Curve™ Semirigid mitral annuloplasty ring

Applicant Corcym S.r.l.

K number K261707

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KRH 2026-04-14

TriMemo™ SEMIRIGID ANNULOPLASTY RING

Applicant Corcym S.r.l.

K number K260498

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KRH 2025-10-29

Seguin Annuloplasty Ring

Applicant ABBOTT MEDICAL

K number K253232

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KRH 2025-09-23

Edwards MC3 Tricuspid annuloplasty ring (4900)

Applicant Edwards Lifesciences, LLC

K number K251982

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KRH 2025-09-17

Carpentier-Edwards Physio Annuloplasty Ring (4450)

Applicant Edwards Lifesciences, LLC

K number K251688

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KRH 2025-07-25

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Applicant Genesee Biomedical, Inc.

K number K250859

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KRH 2024-04-09

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Applicant Genesee Biomedical, Inc.

K number K232599

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KRH 2023-05-26

WellsForm Tricuspid Annuloplasty Band (WF)

Applicant Genesee Biomedical, Inc.

K number K230679

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KRH 2023-04-07

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

Applicant Corcym S.r.l.

K number K230318

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KRH 2020-10-06

TruForm Sievers Annuloplasty Ring

Applicant Genesee Biomedical, Inc.

K number K202253

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KRH 2020-07-01

SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring

Applicant Medtronic, Inc.

K number K201449

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KRH 2019-12-16

Physio Flex Annuloplasty Ring

Applicant Edwards Lifesciences, LLC

K number K192762

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KRH 2019-04-18

NeoForm Annuloplasty Ring

Applicant Genesee Biomedical, Inc.

K number K190506

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KRH 2018-05-29

Tri-Ad 2.0 Adams Tricuspid Band

Applicant Medtronic

K number K181132

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KRH 2018-03-16

MEMO 4D

Applicant Sorin Group Italia S.R.L.

K number K180411

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KRH 2016-10-12

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

Applicant Genesee Biomedical, Inc.

K number K161815

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KRH 2011-06-24

CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

Applicant Edwards Lifesciences, LLC

K number K103520

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KRH 2011-05-18

MITRA-LIFT

Applicant Sciencity Co., Ltd.

K number K103812

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KRH 2010-08-07

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

Applicant Medtronic, Inc.

K number K101212

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KRH 2010-07-15

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC

Applicant Genesee Biomedical, Inc.

K number K093903

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KRH 2009-10-16

SJM ATTUNE ANNULOPLASTY RING

Applicant St Jude Medical

K number K092876

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KRH 2009-08-27

SEGUIN ANNULOPLASTY RING

Applicant St Jude Medical

K number K092310

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KRH 2009-05-07

ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

Applicant Genesee Biomedical, Inc.

K number K090428

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KRH 2009-04-15

CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100

Applicant Edwards Lifesciences, LLC

K number K083623

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KRH 2009-04-10

DETLOGIX ANNULOPLASTY RING, MODEL: 5100

Applicant Edwards Lifesciences, LLC

K number K083191

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KRH 2009-02-25

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC

Applicant Genesee Biomedical, Inc.

K number K083683

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KRH 2009-01-23

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR

Applicant St Jude Medical

K number K083835

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KRH 2009-01-23

CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200

Applicant Edwards Lifesciences, LLC

K number K083470

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KRH 2008-09-04

MICARDIA ANNULOPLASTY BAND DR

Applicant Micardia Corporation

K number K070488

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KRH 2008-03-13

MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R

Applicant Medtronic, Inc.

K number K073324

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KRH 2007-10-23

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR

Applicant Genesee Biomedical, Inc.

K number K072655

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KRH 2007-08-10

MEMO 3D SEMIRIGID ANNULOPLASTY RING

Applicant Sorin Biomedica Cardio S.R.L.

K number K071327

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KRH 2007-08-03

UNIRING - ANNULOPLASTY RING WITH SIZERS

Applicant Peters Surgical

K number K071281

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KRH 2007-07-31

ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING

Applicant Genesee Biomedical, Inc.

K number K071214

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KRH 2006-05-23

CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R

Applicant Medtronic Vascular

K number K061127

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KRH 2006-01-11

SIMPLICI-T ANNULOPLASTY SYSTEM

Applicant Medtronic Heart Valves

K number K052970

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KRH 2005-11-17

ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC

Applicant Genesee Biomedical, Inc.

K number K052899

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KRH 2005-11-17

ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF

Applicant Genesee Biomedical, Inc.

K number K052565

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KRH 2005-11-10

CG FUTURE ANNULOPLASTY BAND

Applicant Medtronic Heart Valves

K number K052860

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KRH 2004-12-17

SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

Applicant St. Jude Medical, Inc.

K number K042734

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KRH 2004-08-03

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

Applicant Medical Cv, Inc.

K number K033685

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KRH 2003-12-05

DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

Applicant Medtronic Heart Valves

K number K032810

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KRH 2003-08-26

GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200

Applicant Edwards Lifesciences, LLC

K number K032250

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KRH 2003-06-04

SHELHIGH BIORING

Applicant Shelhigh, Inc.

K number K023940

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KRH 2002-12-17

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

Applicant Sulzer Carbomedics, Inc.

K number K023185

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KRH 2002-09-19

SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)

Applicant St. Jude Medical, Inc.

K number K022363

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KRH 2002-04-23

ANNULOFLO SYSTEM, MITRAL MODEL AR700

Applicant Sulzer Carbomedics, Inc.

K number K021051

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KRH 2002-04-17

EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900

Applicant Edwards Lifesciences, LLC

K number K020864

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KRH 2002-01-15

SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)

Applicant St. Jude Medical, Inc.

K number K014161

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KRH 2002-01-04

SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)

Applicant St. Jude Medical, Inc.

K number K014037

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KRH 2001-07-12

MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

Applicant Medtronic Vascular

K number K011395

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KRH 2000-02-17

SJM TAILOR ANNULOPLASTY RING, MODEL TARN

Applicant St. Jude Medical, Inc.

K number K000119

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KRH 1999-10-12

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

Applicant Sulzer Carbomedics, Inc.

K number K992056

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KRH 1999-01-07

MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M

Applicant Medtronic Vascular

K number K984435

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KRH 1998-07-07

CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM

Applicant Baxter Edwards

K number K980487

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KRH 1998-04-30

DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H

Applicant The Heart Valve Div. Medtronic Cardiovascular Surg

K number K980534

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KRH 1997-07-25

ANNULOFLO SYSTEM

Applicant Carbomedics, Inc.

K number K970375

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KRH 1997-02-14

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M

Applicant St. Jude Medical, Inc.

K number K961246

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KRH 1996-08-27

POSTERIOR ANNULOPLASTY BAND (MODEL 607)

Applicant The Heart Valve Div. Medtronic Cardiovascular Surg

K number K960356

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KRH 1993-06-22

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

Applicant Baxter Healthcare Corp

K number K926138

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KRH 1993-01-06

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

Applicant Baxter Healthcare Corp

K number K923367

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KRH 1992-02-14

PTI ANNULOPLASTY RING(STERILE)

Applicant Pioneering Technologies, Inc.

K number K905175

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KRH 1992-01-09

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS

Applicant Baxter Healthcare Corp

K number K914972

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KRH 1991-11-22

DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

Applicant The Heart Valve Div. Medtronic Cardiovascular Surg

K number K914602

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KRH 1991-09-09

ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI

Applicant Baxter Healthcare Corp

K number K912554

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KRH 1991-01-18

BIFLEX(TM) ANNULOPLASTY RING

Applicant St. Jude Medical, Inc.

K number K902159

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KRH 1989-11-27

DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H

Applicant Medtronic Blood Systems, Inc.

K number K893678

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KRH 1983-07-29

PROSTHETIC RINGS #4400 MITRAL & 4500

Applicant American Edwards Laboratories

K number K831949

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KRH 1982-06-16

PUIG MASSANA-SHILEY ANNULOPLASTY RING

Applicant Shiley, Inc.

K number K821261

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KRH 1980-12-16

PUIG MASSANA-SHILEY ANNULOPLASTY RING

Applicant Shiley, Inc.

K number K801879

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KRH 1980-04-24

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.

Applicant Usifroid

K number K800147

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KRH 1980-03-17

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

Applicant Edwards Laboratories

K number K792441

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KRH 1980-02-11

AMP DIRECT VASCULAR MONITORING SYSTEM

Applicant American Medical Products, Inc.

K number K792646

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KRH 1979-03-26

MERSILENE SUTURES

Applicant Hancock Laboratories, Inc.

K number K790534

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