Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Recalls
  • Print
  • Share
  • E-mail
-
1 to 281 of 281 Results
Product: pacemaker
Results per Page
New Searchexport reports to excelExport to Excel | HelpHelp
Product Description
Sort by Product Name [A-Z]
Sort by Product Name [Z-A]
Recall
Class
Sort by Recall Class [0-9]
Sort by Recall Class [9-0]
FDA Recall
Posting Date
Sort by Date Classified [0-9]
Sort by Date Classified [9-0]
Recalling Firm
Sort by Recalling Firm [A-Z]
Sort by Recalling Firm [Z-A]
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PAC... 2 03/25/2025 MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE... 2 03/25/2025 MEDLINE INDUSTRIES, LP - Northfield
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) 1 01/10/2025 Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L... 1 01/10/2025 Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), a... 1 01/10/2025 Boston Scientific Corporation
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), an... 1 01/10/2025 Boston Scientific Corporation
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS8402... 2 12/05/2024 MEDLINE INDUSTRIES, LP - Northfield
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can de... 3 11/26/2024 Remote Diagnostic Technologies Ltd.
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 2 11/14/2024 AVID Medical, Inc.
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10 2 11/14/2024 AVID Medical, Inc.
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 2 11/14/2024 AVID Medical, Inc.
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 2 11/14/2024 AVID Medical, Inc.
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 2 11/14/2024 AVID Medical, Inc.
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01 2 11/14/2024 AVID Medical, Inc.
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF... 2 10/23/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J;... 2 10/23/2024 MEDLINE INDUSTRIES, LP - Northfield
PACEMAKER PACK, SLCV01J; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZAL... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHIL... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CA... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY C... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2)... 2 08/28/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, ... 2 08/22/2024 MEDLINE INDUSTRIES, LP - Northfield
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, con... 2 06/28/2024 MEDLINE INDUSTRIES, LP - Northfield
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO 2 04/29/2024 Abbott Medical
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) E... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit numb... 2 01/26/2024 American Contract Systems, Inc.
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 28... 2 01/05/2024 Boston Scientific Corporation
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extract... 2 10/10/2023 Cardinal Health 200, LLC
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CH... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CRO... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. O... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
DeRoyal PACEMAKER ICD PACK, REF 89-10216.06 2 12/15/2022 DeRoyal Industries Inc
DeRoyal PACEMAKER ICD PACK, REF 89-10216.03 2 12/15/2022 DeRoyal Industries Inc
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 2 12/15/2022 DeRoyal Industries Inc
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the... 2 11/11/2022 Spectranetics Corporation
Various Pacemaker Packs, Cardio Thoracic Packs 2 09/08/2022 American Contract Systems, Inc.
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular a... 2 09/14/2021 Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular ... 2 09/14/2021 Philips North America Llc
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added... 1 07/13/2021 Boston Scientific Corporation
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added... 1 07/13/2021 Boston Scientific Corporation
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added ... 1 07/13/2021 Boston Scientific Corporation
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 2 07/02/2021 Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 2 07/02/2021 Boston Scientific Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 2 07/02/2021 Boston Scientific Corporation
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 2 07/02/2021 Boston Scientific Corporation
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131 2 07/02/2021 Boston Scientific Corporation
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 2 07/02/2021 Boston Scientific Corporation
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 1 06/10/2021 DeRoyal Industries Inc
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and ... 1 05/07/2021 St. Jude Medical, Cardian Rhythm Management Division
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacema... 1 05/07/2021 St. Jude Medical, Cardian Rhythm Management Division
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, I... 2 12/28/2020 ROi CPS LLC
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implanta... 2 03/19/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron... 2 03/19/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MN... 2 02/05/2020 Centurion Medical Products Corporation
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single... 2 10/04/2019 AZIYO BIOLOGICS
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2... 2 10/04/2019 AZIYO BIOLOGICS
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. 2 09/09/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardi... 2 09/09/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the followin... 2 02/27/2019 American Contract Systems, Inc.
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model ... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED0... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pace... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemak... 1 02/14/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) 2 09/27/2018 Boston Scientific Corporation
PROPONENT Pacemaker 2 09/27/2018 Boston Scientific Corporation
ACCOLADE Pacemaker 2 09/27/2018 Boston Scientific Corporation
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) 2 09/27/2018 Boston Scientific Corporation
ESSENTIO Pacemaker 2 09/27/2018 Boston Scientific Corporation
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,includin... 2 07/25/2018 Philips Healthcare
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including d... 2 07/25/2018 Philips Healthcare
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,incl... 2 07/25/2018 Philips Healthcare
Single Chamber Temporary External Pacemaker, Model 53401 2 06/29/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pa... 2 06/12/2018 St Jude Medical Inc.
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, inten... 2 06/12/2018 St Jude Medical Inc.
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implanta... 2 06/12/2018 St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devic... 2 06/12/2018 St Jude Medical Inc.
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pace... 2 06/12/2018 St Jude Medical Inc.
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional... 2 05/01/2018 Philips Electronics North America Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL® Connector, REF/Catalog Number 2602Z Indicat... 2 03/24/2018 ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602... 2 03/24/2018 ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602... 2 03/24/2018 ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602... 2 03/24/2018 ConMed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control® Quik-Combo" Connector, REF/Catalog Nu... 2 03/24/2018 ConMed Corporation
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06 ... 2 02/28/2018 Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016 ... 2 02/28/2018 Avid Medical, Inc.
AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09 2 02/28/2018 Avid Medical, Inc.
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage.... 2 02/24/2018 Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 a... 2 02/24/2018 Philips Electronics North America Corporation
PROPONENT DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
PROPONENT EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
PROPONENT VDD SL Pacemaker 2 01/15/2018 Boston Scientific Corporation
PROPONENT MRI Pacemaker 2 01/15/2018 Boston Scientific Corporation
VALITUDE X4 CRT-P Pacemaker 2 01/15/2018 Boston Scientific Corporation
VALITUDE CRT-P Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE MRI EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE MRI DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE MRI SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ACCOLADE SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
PROPONENT SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO MRI EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO MRI DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO MRI SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ESSENTIO SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
VISIONIST X4 CRT-P Pacemaker 2 01/15/2018 Boston Scientific Corporation
VISIONIST CRT-P Pacemaker 2 01/15/2018 Boston Scientific Corporation
ALTRUA 2 SR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ALTRUA 2 DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
ALTRUA 2 EL DR Pacemaker 2 01/15/2018 Boston Scientific Corporation
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The ... 2 12/18/2017 Philips Electronics North America Corporation
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposab... 1 04/10/2017 Oscor, Inc.
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Ser... 1 04/10/2017 Oscor, Inc.
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU 2 03/24/2017 Resource Optimization & Innovation Llc
Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU 2 03/24/2017 Resource Optimization & Innovation Llc
Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number... 2 02/28/2017 Windstone Medical Packaging, Inc.
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, inc... 2 01/20/2017 Philips Electronics North America Corporation
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, inc... 2 01/20/2017 Philips Electronics North America Corporation
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications... 2 01/20/2017 Philips Electronics North America Corporation
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applicati... 2 01/20/2017 Philips Electronics North America Corporation
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and i... 2 11/15/2016 Sorin Group USA, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program ... 2 11/15/2016 Sorin Group USA, Inc.
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital op... 2 10/20/2016 Windstone Medical Packaging, Inc.
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5)... 2 09/19/2016 Medtronic Inc., Cardiac Rhythm and Heart Failure
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L1... 2 09/07/2016 Boston Scientific Corporation
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of impla... 2 08/15/2016 TYRX Inc.
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pace... 2 08/15/2016 TYRX Inc.
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted p... 2 08/15/2016 TYRX Inc.
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C,... 2 03/31/2016 Philips Medical Systems, Inc.
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura X... 2 03/07/2016 Philips Electronics North America Corporation
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular ... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applicati... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applicati... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imagin... 2 01/30/2016 Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform:... 2 01/30/2016 Philips Electronics North America Corporation
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to p... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imag... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascula... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascu... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applicati... 2 01/30/2016 Philips Electronics North America Corporation
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging... 2 01/30/2016 Philips Electronics North America Corporation
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists ... 2 01/30/2016 Philips Electronics North America Corporation
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (... 2 01/30/2016 Philips Electronics North America Corporation
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a de... 3 12/22/2015 BC Group International Inc
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper se... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper seri... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 ... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series i... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper se... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper ser... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper serie... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 All... 2 12/01/2015 Philips Medical Systems, Inc.
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series... 2 12/01/2015 Philips Medical Systems, Inc.
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. 2 11/27/2015 Medtronic Inc.
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, ... 2 11/06/2015 DeRoyal Industries Inc
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630... 2 11/06/2015 DeRoyal Industries Inc
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light ha... 2 10/07/2015 Resource Optimization & Innovation Llc
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of ... 2 10/05/2015 Medtronic Inc. Cardiac Rhythm Disease Management
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support ... 2 09/28/2015 St Jude Medical Cardiac Rhythm Management Division
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Sof... 2 08/13/2015 BIOTRONIK, Inc.
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-1212... 2 06/25/2015 DeRoyal Industries Inc
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary ... 2 03/31/2015 Medtronic Inc. Cardiac Rhythm Disease Management
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) 2 01/08/2015 Centurion Medical Products Corporation
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary P... 2 05/24/2014 Medtronic Inc. Cardiac Rhythm Disease Management
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Ver... 2 03/31/2014 ZOLL Medical Corporation
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during... 2 03/06/2013 Atricure Inc
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified me... 2 09/17/2012 ZOLL Medical Corporation
Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC... 3 04/17/2012 Deroyal Industries, Inc. Lafollette
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce... 2 02/15/2012 European Custom Manufacturing B.V.
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and ... 2 01/11/2012 St Jude Medical CRMD
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient'... 2 01/11/2012 St Jude Medical CRMD
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR ta... 2 08/10/2011 Philips Healthcare Inc.
Material CVI3030, TEMPORARY PACEMAKER INSERTION TRAY, CENTURION TEMPORARY PACEMAKER INSERTION TRAY, ... 2 05/27/2011 Centurion Medical Products Corporation
Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is... 2 05/25/2011 ZOLL Medical Corporation
Medstorm Adult Radiolucent Electrode  Philips Medical , Part #16250, HeartSync Ann Arbor, MI. Th... 2 02/18/2011 Heart Sync, Inc
Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The Adult Radio... 2 02/18/2011 Heart Sync, Inc
Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtron... 2 11/22/2010 Medtronic Inc. Cardiac Rhythm Disease Managment
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imag... 2 10/22/2010 Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray ima... 2 10/22/2010 Philips Medical Systems North America Co. Phillips
Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse ge... 2 09/21/2010 Osypka Medical Inc
St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 exte... 2 09/21/2010 Osypka Medical Inc
Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical d... 2 08/09/2010 Stryker Endoscopy
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0... 2 05/07/2010 ZOLL Medical Corporation, World Wide Headquarters
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The ... 2 04/26/2010 Medtronic Inc. Cardiac Rhythm Disease Managment
ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose... 2 09/29/2009 ZOLL Medical Corporation, World Wide Headquarters
Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM... 2 09/24/2009 ela Medical Llc
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, model... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive ... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR20... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular us... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Single Chamber Rate Responsiv... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and S... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303. 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 057... 2 09/24/2008 Oscor, Inc.
3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 4... 2 06/25/2008 Medline Industries Inc
Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 5543... 3 11/06/2007 Medtronic Inc. Cardiac Rhythm Managment
Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assem... 2 08/29/2007 DeRoyal Lafollette
Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C... 2 07/07/2007 Medtronic Inc. Cardiac Rhythm Managment
Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber ... 2 07/07/2007 Medtronic Inc. Cardiac Rhythm Managment
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse... 2 12/19/2006 St Jude Medical CRMD
Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar,... 2 11/09/2006 Enpath Medical, Inc
Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482), VDD (model 88... 2 09/28/2006 Boston Scientific CRM Corp
Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194); and DR (mode... 2 09/28/2006 Boston Scientific CRM Corp
Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); and DR (mod... 2 09/28/2006 Boston Scientific CRM Corp
Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and ... 2 09/28/2006 Boston Scientific CRM Corp
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway S... 3 05/31/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, S... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS30... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacin... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular us... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventil... 2 12/02/2005 ela Medical Llc
Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker tha... 2 12/02/2005 ela Medical Llc
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (model... 2 11/23/2005 Guidant Corporation
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models... 2 11/23/2005 Guidant Corporation
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882)... 2 11/23/2005 Guidant Corporation
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 04... 2 11/23/2005 Guidant Corporation
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (mod... 2 09/24/2005 Guidant Corporation
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (mo... 2 09/24/2005 Guidant Corporation
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0... 2 09/24/2005 Guidant Corporation
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 88... 2 09/24/2005 Guidant Corporation
Custom Procedure Trays, containing various configurations of medical and surgical devices, packed i... 2 09/14/2005 Avid Medical Inc
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P56... 2 08/03/2005 B. Braun Medical, Inc.
VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxide. Gui... 1 07/28/2005 Guidant Corporation
DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Steriliz... 1 07/28/2005 Guidant Corporation
PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. ... 1 07/28/2005 Guidant Corporation
CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporatio... 1 07/28/2005 Guidant Corporation
MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. ... 1 07/28/2005 Guidant Corporation
DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with gaseous ethylene ... 1 07/28/2005 Guidant Corporation
INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gas... 1 07/28/2005 Guidant Corporation
PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. S... 1 07/28/2005 Guidant Corporation
Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for... 2 07/20/2004 Medtronic Inc. Cardiac Rhythm Managment
Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for... 2 07/20/2004 Medtronic Inc. Cardiac Rhythm Managment
Discovery II Multiprogrammable Pacemaker, Model 1286 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1284 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1283 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1184 2 07/15/2003 Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1280 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 0481 2 07/15/2003 Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1181 2 07/15/2003 Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1180 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 0981 2 07/15/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, DDD Model 981 2 05/29/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, DDDR Model 1280 2 05/29/2003 Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, DDDR Model 1283 2 05/29/2003 Guidant Corp-Cpi Division
Meridian Multiprogrammable Pacemaker, DDDR Model 1275 2 05/29/2003 Guidant Corp-Cpi Division
Meridian Multiprogrammable Pacemaker, DDDR Model 1276 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Plus Multiprogrammable Pacemaker, DDD Model 985 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Plus Multiprogrammable Pacemaker, DDD Model 986 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1294 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297 2 05/29/2003 Guidant Corp-Cpi Division
Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1298 2 05/29/2003 Guidant Corp-Cpi Division
Contak TR Multiprogrammable Pacemaker, DDDR Model 1241 2 05/29/2003 Guidant Corp-Cpi Division
Discovery Multiprogrammable Pacemaker, DDDR Model 1274 2 05/29/2003 Guidant Corp-Cpi Division
Discovery Multiprogrammable Pacemaker, DDDR Model 1273 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1286 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1284 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Max Multiprogrammable Pacemaker 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Multiprogrammable Pacemaker, DDDR Model 1272 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Multiprogrammable Pacemaker, DDDR Model 1270 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Multiprogrammable Pacemaker, DDD Model 976 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Multiprogrammable Pacemaker, DDD Model 970 2 05/29/2003 Guidant Corp-Cpi Division
Pulsar Multiprogrammable Pacemaker, DDD Model 972 2 05/29/2003 Guidant Corp-Cpi Division
Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo... 2 12/18/2002 St Jude Medical
 
 
-
-