ClearanceBrief
Product code NIK ยท Class 3

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

0510(k)s in 12 months (0 all time)
0recalls in 12 months (153 all time)
0recalls that name a 510(k)
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Top companies in NIK

DateFirm and productCodeLinked 510(k)
Jun 26, 2024Medtronic Inc.
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Jun 26, 2024Medtronic Inc.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Jun 26, 2024Medtronic Inc.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Jun 26, 2024Medtronic Inc.
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Jun 26, 2024Medtronic Inc.
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Jun 26, 2024Medtronic Inc.
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Open, Classified
NIKNone listed
Sep 19, 2023Abbott Medical
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchr
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed

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