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Medtronic Inc. Cardiac Rhythm Disease Management

37 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of recall (Z-0022-2016)Medtronic Inc. Cardiac Rhythm Disease Management2015-10-05
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac abla recall (Z-2777-2015)Medtronic Inc. Cardiac Rhythm Disease Management2015-09-17
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models recall (Z-1365-2015)Medtronic Inc. Cardiac Rhythm Disease Management2015-04-02
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The tempor recall (Z-1356-2015)Medtronic Inc. Cardiac Rhythm Disease Management2015-03-31
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sh recall (Z-1276-2015)Medtronic Inc. Cardiac Rhythm Disease Management2015-03-17
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) T recall (Z-1661-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-05-24
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). N recall (Z-0995-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, recall (Z-0996-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, recall (Z-0997-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 788 recall (Z-0998-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.) recall (Z-0999-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cann recall (Z-1000-2014)Medtronic Inc. Cardiac Rhythm Disease Management2014-02-20
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, recall (Z-2104-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-27
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 recall (Z-2105-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-27
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leach recall (Z-2106-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-27
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylen recall (Z-1966-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-14
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardi recall (Z-1876-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-05
Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, M recall (Z-1607-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-06-27
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # recall (Z-1564-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-06-21
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to f recall (Z-1017-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-03-28
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, a recall (Z-1019-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-03-28
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass p recall (Z-0908-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-03-05
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact recall (Z-0618-2013)Medtronic Inc. Cardiac Rhythm Disease Management2012-12-28
Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ve recall (Z-1248-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-03-22
Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular recall (Z-1249-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-03-22
Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular T recall (Z-1250-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-03-22
Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile E recall (Z-0807-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model recall (Z-0808-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyro recall (Z-0809-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethy recall (Z-0810-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic, DLP, DLP Malleable Single Stage Venous CannulaeRx Only, Sterilized Using Ethyle recall (Z-0811-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterili recall (Z-0812-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, recall (Z-0813-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, recall (Z-0814-2012)Medtronic Inc. Cardiac Rhythm Disease Management2012-01-18
Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H recall (Z-0149-2012)Medtronic Inc. Cardiac Rhythm Disease Management2011-11-02
Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a perc recall (Z-3186-2011)Medtronic Inc. Cardiac Rhythm Disease Management2011-09-12
Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable recall (Z-2120-2011)Medtronic Inc. Cardiac Rhythm Disease Management2011-04-29

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Every clearance here is in the API, with alerts when new ones post.