Product code LWS ยท Class 3
Implantable Cardioverter Defibrillator (Non-Crt)
0510(k)s in 12 months (0 all time)
1recalls in 12 months (219 all time)
0recalls that name a 510(k)
Top companies in LWS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2021 | Boston Scientific Corporation EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD) Terminated |
LWS | None listed |
| Dec 2, 2020 | Boston Scientific Corporation EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219 Open, Classified |
LWS | None listed |
| Dec 2, 2020 | Boston Scientific Corporation EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209 Open, Classified |
LWS | None listed |
| Sep 22, 2020 | Boston Scientific Corporation Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Terminated |
LWS | None listed |
| Mar 3, 2020 | Boston Scientific Corporation Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachyc Terminated |
LWS | None listed |
| Mar 3, 2020 | Boston Scientific Corporation Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate wi Terminated |
LWS | None listed |
| Aug 21, 2019 | Boston Scientific Corporation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator Open, Classified |
LWS | None listed |
| Aug 21, 2019 | Boston Scientific Corporation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator Open, Classified |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, REF: CD2377-36QC
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, REF: CD1377-36QC
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, REF: CD1377-36C
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Nov 1, 2018 | Boston Scientific Corporation The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
The S-ICD System is intended to provide defibrillation therapy for the treatment of li Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation Model 3300 LATITUDE(TM) Programming System
Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scie Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation ACCOLADE Pacemaker Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation PROPONENT Pacemaker Terminated |
LWS | None listed |
| Sep 10, 2018 | Boston Scientific Corporation ESSENTIO Pacemaker Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust Escudo D144DRG (OUS distribution)
Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust Escudo D144VRC (OUS distribution)
Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC
Product Usage: The implantable cardioverter defibrillator Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC
Product Usage: The implantable cardioverter defibrillator Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG
Product Usage:
The device indicated for use in ICD patient Terminated |
LWS | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG
Product Usage:
The device indicated for use in ICD patient Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Promote Quadra, Sterile EO, Model # / Part #:
CD3221-36/100025054, 60019195;
CD3223-36P/100013763;
CD3239-40/100029115, 100029254, 100037181;
CD3239-40Q/100029116, 100029244, 100037115 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Promote, Sterile EO, Model #/ Part #:
3207-30/60010740-207, 60010740-407;
3207-36/60010743-207, 60010743-407;
3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707;
CD3211-36/100006984,10 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Fortify Assura, Sterile EO, Model #/ Part #:
CD1257-40/100042322, 100059623;
CD1257-40Q/100042341, 100059535;
CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567;
CD1259-40Q/100041931, Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Fortify, Sterile EO, Model #/ Part #:
CD1231-40/100029238,100030095, 100041981;
CD1231-40Q/100029229, 100030087, 100041982;
CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Ellipse, Sterile EO, Model #/ Part #:
CD1275-36/100116115;
CD1275-36Q/100116116;
CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636;
CD1277-36Q/100048374, 100048394, 100060198, 10009849 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Current, Sterile EO, Model #/ Part #:
1207-30/50020236-001, 60010739-207, 60010739-407;
1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707;
2207-30/ 50020238-001, 60010738- Terminated |
LWS | None listed |
| Feb 1, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as:
a. Visia AF VR ICD DF1 (Product No. DVAB1D1);
EXPANSION:
b. Visia AF" VR ICD DF4 (Product No. DVAB1D4)
Implantable device Terminated |
LWS | None listed |
| Feb 1, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following:
a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1);
b. Visia AF MRI VR SureScan ICD DF4 (Product No. D Terminated |
LWS | None listed |
| Feb 1, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following:
a. Evera S DR ICD DF1 (Product No. DDBC3D1);
b. Evera S VR ICD DF1 (Product No. DVBC3D1);
c. Evera S VR ICD DF4 (P Terminated |
LWS | None listed |
| Feb 1, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following:
a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1);
b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4);
c. Evera Terminated |
LWS | None listed |
| Oct 10, 2017 | St Jude Medical Inc. Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify A Terminated |
LWS | None listed |
| Oct 4, 2017 | Boston Scientific Corporation RESONATE EL ICD DR, Model D433, Sterile. Terminated |
LWS | None listed |
| Oct 4, 2017 | Boston Scientific Corporation RESONATE EL ICD VR, Model D432, Sterile. Terminated |
LWS | None listed |
| Aug 16, 2017 | Boston Scientific Corporation SQ-RX 1010 Pulse Generator, Rx.
Product Usage:
The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do Terminated |
LWS | None listed |
| Aug 16, 2017 | Boston Scientific Corporation EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx.
Product Usage:
The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr Terminated |
LWS | None listed |
| Aug 16, 2017 | Boston Scientific Corporation EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX.
Product Usage:
The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threate Terminated |
LWS | None listed |
| Jan 12, 2017 | Boston Scientific Corporation Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. Terminated |
LWS | None listed |
| Oct 21, 2016 | St Jude Medical Inc. Unify, Model No. CD3231-40, CD3231-40Q.
Unify Quadra, Model No. CD3249-40, CD3249-40Q.
Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q.
Fortify and Fortify Assura implantable cardioverter de Terminated |
LWS | None listed |
| Oct 21, 2016 | St Jude Medical Inc. Fortify VR, Model No. CD1231-40, CD1231-40Q.
Fortify ST VR, Model No. CD1241-40, CD1241-40Q.
Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C.
Fortify Assura ST VR, Model No. CD1263-40, Terminated |
LWS | None listed |
| Aug 25, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Evera Implantable Cardioverter Defibrillators:
Product Model
EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1.
EVERA S DDBC3D1, DDBC3D4
Product Usage:
The Medtron Terminated |
LWS | None listed |
| Aug 25, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators:
Product Model
VIVAXTCRT-D DTBA1D1, DTBA1D4
VIVASCRT-D DTBB1D1, DTBB1D4
Product Usage:
The Medtronic Viva Terminated |
LWS | None listed |
| Mar 31, 2016 | St Jude Medical Inc. Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C
Product Usage:
Ellipse ICD devices are intended to provide ventricular antitachycardia pacing Terminated |
LWS | None listed |
| Jan 21, 2016 | St Jude Medical Cardiac Rhythm Management Division Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrilla Terminated |
LWS | None listed |
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