ClearanceBrief
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)
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Top companies in LWS

DateFirm and productCodeLinked 510(k)
Jan 19, 2021Boston Scientific Corporation
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Terminated
LWSNone listed
Dec 2, 2020Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Open, Classified
LWSNone listed
Dec 2, 2020Boston Scientific Corporation
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Open, Classified
LWSNone listed
Sep 22, 2020Boston Scientific Corporation
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Terminated
LWSNone listed
Mar 3, 2020Boston 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
LWSNone listed
Mar 3, 2020Boston 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
LWSNone listed
Aug 21, 2019Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Open, Classified
LWSNone listed
Aug 21, 2019Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Open, Classified
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
Terminated
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Terminated
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Terminated
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
Terminated
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Terminated
LWSNone listed
Aug 2, 2019St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Terminated
LWSNone listed
Nov 1, 2018Boston 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
LWSNone listed
Sep 10, 2018Boston 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
LWSNone listed
Sep 10, 2018Boston Scientific Corporation
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Terminated
LWSNone listed
Sep 10, 2018Boston Scientific Corporation
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Terminated
LWSNone listed
Sep 10, 2018Boston Scientific Corporation
ACCOLADE Pacemaker
Terminated
LWSNone listed
Sep 10, 2018Boston Scientific Corporation
PROPONENT Pacemaker
Terminated
LWSNone listed
Sep 10, 2018Boston Scientific Corporation
ESSENTIO Pacemaker
Terminated
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Jul 10, 2018Medtronic 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Apr 16, 2018St 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
LWSNone listed
Feb 1, 2018Medtronic 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
LWSNone listed
Feb 1, 2018Medtronic 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
LWSNone listed
Feb 1, 2018Medtronic 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
LWSNone listed
Feb 1, 2018Medtronic 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
LWSNone listed
Oct 10, 2017St 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
LWSNone listed
Oct 4, 2017Boston Scientific Corporation
RESONATE EL ICD DR, Model D433, Sterile.
Terminated
LWSNone listed
Oct 4, 2017Boston Scientific Corporation
RESONATE EL ICD VR, Model D432, Sterile.
Terminated
LWSNone listed
Aug 16, 2017Boston 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
LWSNone listed
Aug 16, 2017Boston 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
LWSNone listed
Aug 16, 2017Boston 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
LWSNone listed
Jan 12, 2017Boston Scientific Corporation
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Terminated
LWSNone listed
Oct 21, 2016St 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
LWSNone listed
Oct 21, 2016St 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
LWSNone listed
Aug 25, 2016Medtronic 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
LWSNone listed
Aug 25, 2016Medtronic 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
LWSNone listed
Mar 31, 2016St 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
LWSNone listed
Jan 21, 2016St 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
LWSNone listed

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