Panels › Cardiovascular › Product code KRH · Class 2
Ring, Annuloplasty
Regulation 870.3800
2510(k)s in 12 months (75 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KRH
| Company | 510(k)s | Recalls |
|---|---|---|
| Genesee Biomedical, Inc. | 13 | 0 |
| St Jude Medical | 10 | 0 |
| Edwards Lifesciences, LLC | 9 | 0 |
| Baxter Healthcare Corp | 4 | 0 |
| Medtronic | 4 | 0 |
| Corcym S.r.l. | 3 | 0 |
| The Heart Valve Div. Medtronic Cardiovascular Surg | 3 | 0 |
| Medtronic Heart Valves | 3 | 0 |
| Medtronic Vascular | 3 | 0 |
| Sulzer Carbomedics, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring Corcym S.r.l., IT | KRH |
| Apr 14, 2026 | K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING Corcym S.r.l., IT | KRH |
| Oct 29, 2025 | K253232 | Seguin Annuloplasty Ring ABBOTT MEDICAL | KRH |
| Sep 23, 2025 | K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) Edwards Lifesciences, LLC | KRH |
| Sep 17, 2025 | K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) Edwards Lifesciences, LLC | KRH |
| Jul 25, 2025 | K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) Genesee Biomedical, Inc. | KRH |
| Apr 9, 2024 | K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) Genesee Biomedical, Inc. | KRH |
| May 26, 2023 | K230679 | WellsForm Tricuspid Annuloplasty Band (WF) Genesee Biomedical, Inc. | KRH |
| Apr 7, 2023 | K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring Corcym S.r.l., IT | KRH |
| Oct 6, 2020 | K202253 | TruForm Sievers Annuloplasty Ring Genesee Biomedical, Inc. | KRH |
| Jul 1, 2020 | K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Medtronic, Inc. | KRH |
| Dec 16, 2019 | K192762 | Physio Flex Annuloplasty Ring Edwards Lifesciences, LLC | KRH |
| Apr 18, 2019 | K190506 | NeoForm Annuloplasty Ring Genesee Biomedical, Inc. | KRH |
| May 29, 2018 | K181132 | Tri-Ad 2.0 Adams Tricuspid Band Medtronic | KRH |
| Mar 16, 2018 | K180411 | MEMO 4D Sorin Group Italia S.R.L., IT | KRH |
| Oct 12, 2016 | K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Genesee Biomedical, Inc. | KRH |
| Aug 29, 2014 | K142221 | MEMO 3D ReChord Sorin Group Italia S.R.L., IT | KRH |
| Jun 24, 2011 | K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING Edwards Lifesciences, LLC | KRH |
| May 18, 2011 | K103812 | MITRA-LIFT Sciencity Co., Ltd. | KRH |
| Aug 7, 2010 | K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R Medtronic, Inc. | KRH |
| Jul 15, 2010 | K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC Genesee Biomedical, Inc. | KRH |
| Oct 16, 2009 | K092876 | SJM ATTUNE ANNULOPLASTY RING St Jude Medical | KRH |
| Aug 27, 2009 | K092310 | SEGUIN ANNULOPLASTY RING St Jude Medical | KRH |
| May 7, 2009 | K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC Genesee Biomedical, Inc. | KRH |
| Apr 15, 2009 | K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 Edwards Lifesciences, LLC | KRH |
| Apr 10, 2009 | K083191 | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 Edwards Lifesciences, LLC | KRH |
| Feb 25, 2009 | K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC Genesee Biomedical, Inc. | KRH |
| Jan 23, 2009 | K083835 | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR St Jude Medical | KRH |
| Jan 23, 2009 | K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 Edwards Lifesciences, LLC | KRH |
| Sep 4, 2008 | K070488 | MICARDIA ANNULOPLASTY BAND DR Micardia Corporation | KRH |
| Mar 13, 2008 | K073324 | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R Medtronic, Inc. | KRH |
| Oct 23, 2007 | K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR Genesee Biomedical, Inc. | KRH |
| Aug 10, 2007 | K071327 | MEMO 3D SEMIRIGID ANNULOPLASTY RING Sorin Biomedica Cardio S.R.L. | KRH |
| Aug 3, 2007 | K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS Peters Surgical, FR | KRH |
| Jul 31, 2007 | K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING Genesee Biomedical, Inc. | KRH |
| May 23, 2006 | K061127 | CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R Medtronic Vascular | KRH |
| Jan 11, 2006 | K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM Medtronic Heart Valves | KRH |
| Nov 17, 2005 | K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC Genesee Biomedical, Inc. | KRH |
| Nov 17, 2005 | K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF Genesee Biomedical, Inc. | KRH |
| Nov 10, 2005 | K052860 | CG FUTURE ANNULOPLASTY BAND Medtronic Heart Valves | KRH |
| Dec 17, 2004 | K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) St. Jude Medical, Inc. | KRH |
| Aug 3, 2004 | K033685 | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 Medical Cv, Inc. | KRH |
| Dec 5, 2003 | K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE Medtronic Heart Valves | KRH |
| Aug 26, 2003 | K032250 | GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 Edwards Lifesciences, LLC | KRH |
| Jun 4, 2003 | K023940 | SHELHIGH BIORING Shelhigh, Inc. | KRH |
| Dec 17, 2002 | K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 Sulzer Carbomedics, Inc. | KRH |
| Sep 19, 2002 | K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) St. Jude Medical, Inc. | KRH |
| Apr 23, 2002 | K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 Sulzer Carbomedics, Inc. | KRH |
| Apr 17, 2002 | K020864 | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 Edwards Lifesciences, LLC | KRH |
| Jan 15, 2002 | K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) St. Jude Medical, Inc. | KRH |
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