EnSite™ X EP System

• DRE Med Registration: 1000122786 View Registration
• MicroPort CRM S.r.l. Registration: 1000165971 View Registration
• C.R. BARD, INC. Registration: 1018233 View Registration
• TOYO MEDICAL CO. Registration: 1054713 View Registration
• TOUCHPOINT MEDICAL, Inc. Registration: 1058031 View Registration
• Sterigenics US LLC Registration: 1058584 View Registration
• ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
• Philips North America LLC Registration: 1218950 View Registration
• RESPIRONICS NOVAMETRIX, LLC Registration: 1219324 View Registration
• NORTHEAST MONITORING, INC. Registration: 1224919 View Registration
• WELCH ALLYN, INC. Registration: 1316463 View Registration
• Graphic Controls Acquisition Corp.dba Nissha Medical Technologies Registration: 1317188 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
• CONMED CORPORATION Registration: 1320894 View Registration
• SCOTTCARE CORPORATION Registration: 1527715 View Registration
• Isomedix Operations Inc. Registration: 1650907 View Registration
• GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Registration: 1651104 View Registration
• Sterigenics U.S., LLC Registration: 1721686 View Registration
• MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
• KATECHO LLC Registration: 1930027 View Registration
• ABBOTT VASCULAR Registration: 2024168 View Registration
• Sterigenics U.S., LLC Registration: 2029275 View Registration
• IRVINE BIOMEDICAL. INC. Registration: 2030404 View Registration
• Phillips-Medisize Costa Mesa LLC Registration: 2031044 View Registration
• Isomedix Operations Inc. Registration: 2032112 View Registration
• Boston Scientific Corporation Registration: 2124215 View Registration
• Lake Region Medical Registration: 2126666 View Registration
• BENCHMARK ELECTRONICS, INC. Registration: 2133641 View Registration
• Spartronics Watertown LLC Registration: 2133772 View Registration
• MINNETRONIX, INC. Registration: 2133810 View Registration
• CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
• TECHNICAL SERVICES FOR ELECTRONICS, INC. Registration: 2135338 View Registration
• MEDTRONIC, INC. Registration: 2182208 View Registration
• Cardinal Health Registration: 2183164 View Registration
• PLEXUS CORP. Registration: 2183715 View Registration
• Isomedix Operations, Inc. Registration: 2183744 View Registration
• Merge Healthcare Incorporated Registration: 2183926 View Registration
• St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2184149 View Registration
• Isomedix Operations Inc. Registration: 2246552 View Registration
• Premier Heart, LLC Registration: 2438852 View Registration
• EDWARDS LIFESCIENCES TECHNOLOGY SARL Registration: 2648045 View Registration
• SCIMAGE, INC. Registration: 2952596 View Registration
• Philips Electronics Ltd Registration: 3000126629 View Registration
• Creation Technologies Ltd Registration: 3000279201 View Registration
• Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
• GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
• LINEMASTER SWITCH CORP. Registration: 3001592626 View Registration
• AMPHENOL DC ELECTRONICS Registration: 3001763079 View Registration
• SPECTRUM ASSEMBLY INC. Registration: 3002672225 View Registration
• STEREOTAXIS, INC. Registration: 3003084417 View Registration
• SPARTRONICS STRONGSVILLE, INC. Registration: 3003144120 View Registration
• ITAMAR MEDICAL Registration: 3003616071 View Registration
• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
• EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
• GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG Registration: 3004006614 View Registration
• SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD. Registration: 3004016520 View Registration
• Abbott Vascular Netherlands Registration: 3004091615 View Registration
• PLEXUS CORP. Registration: 3004105270 View Registration
• Industrial Vallera de Mexicali, S. A. de C. V. Registration: 3004415095 View Registration
• Dedicated Computing LLC Registration: 3004594159 View Registration
• FUJIFILM Healthcare Americas Corporation Registration: 3004972322 View Registration
• Siemens Healthineers AG Registration: 3004977335 View Registration
• Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
• St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
• METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
• C.R. BARD, INC. Registration: 3006082230 View Registration
• WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. Registration: 3006087789 View Registration
• AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
• Cardiabase Registration: 3007184699 View Registration
• IRHYTHM TECHNOLOGIES, INC. Registration: 3007208829 View Registration
• Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
• KARDIUM Inc. Registration: 3007603855 View Registration
• WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
• MEDICALGORITHMICS S.A. Registration: 3007770164 View Registration
• LUMEDX Registration: 3008012314 View Registration
• FOXCONN BAJA CALIFORNIA S.A DE C.V. Registration: 3008093809 View Registration
• Sorin CRM SAS Registration: 3008159616 View Registration
• Biosense Webster (Israel), Ltd. Registration: 3008203003 View Registration
• CARDIOTEK BV Registration: 3008329188 View Registration
• Volcano Corporation Registration: 3008363989 View Registration
• Abbott Medical Costa Rica Ltda. Registration: 3008452825 View Registration
• Technical Services for Electronics, Inc. Registration: 3008483389 View Registration
• QUIPMENT Registration: 3008717264 View Registration
• GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
• DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
• Yokowo Co., Ltd Registration: 3009092139 View Registration
• IMRICOR MEDICAL SYSTEMS Registration: 3009254201 View Registration
• VectraCor, Inc. Registration: 3009443693 View Registration
• EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
• Abbott Medical Registration: 3009600098 View Registration
• AliveCor Registration: 3009715978 View Registration
• MASIMO CORPORATION Registration: 3009831876 View Registration
• SHENZHEN CAREWELL ELECTRONICS CO., LTD. Registration: 3010089768 View Registration
• Synergy Health Sterilisation UK Ltd Registration: 3010155648 View Registration
• Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
• Synergy Health AST, SRL Registration: 3010273872 View Registration
• Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd Registration: 3010288146 View Registration
• CARDIAC INSIGHT, INC. Registration: 3010342616 View Registration
• MEDISONO, LLC Registration: 3010390468 View Registration
• Boston Scientific Corporation Registration: 3010705768 View Registration
• FYSICON BV Registration: 3010716438 View Registration
• Catheter Precision, Incorporated Registration: 3010728615 View Registration
• MASIMO CORPORATION Registration: 3011353843 View Registration
• Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC Registration: 3012027770 View Registration
• SMART SOLUTIONS TECHNOLOGIES S.L. (NUUBO) Registration: 3012032144 View Registration
• CENTERLINE BIOMEDICAL Registration: 3012154226 View Registration
• St. Jude Medical Registration: 3012179728 View Registration
• AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3012260771 View Registration
• Smiths Interconnect Mexico Registration: 3012268816 View Registration
• GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
• MEDTRONIC, INC. Registration: 3012520654 View Registration
• Philips North America LLC Registration: 3012528160 View Registration
• St. Jude Medical Coordination Center BVBA European Distribution Center Registration: 3012552532 View Registration
• Dongguan Ergotron Precision Technology Co., LTD Registration: 3012619193 View Registration
• Microtek Dominicana, S.A.S. Registration: 3012811961 View Registration
• BIOSENSE WEBSTER, INC. Registration: 3013300026 View Registration
• FedEx Supply Chain, Inc. Registration: 3013403214 View Registration
• Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
• CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
• MOLEX S.A. DE C.V. Registration: 3013581838 View Registration
• Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
• Cortex, Inc. Registration: 3013627970 View Registration
• Repair Operations Center Registration: 3013679558 View Registration
• Zurich Medical Inc Registration: 3013943846 View Registration
• Philips Clinical Informatics Registration: 3014128039 View Registration
• ICENTIA Inc Registration: 3014271754 View Registration
• GMED Healthcare BVBA ( a Johnson & Johnson Company) Registration: 3014272734 View Registration
• DREAMTECH CO., LTD. Registration: 3014848734 View Registration
• BOULDER BIOMED LLC Registration: 3015151147 View Registration
• CLEARPATH MEDICAL, LLC Registration: 3016406615 View Registration
• Philips North America LLC Registration: 3016618143 View Registration
• Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Registration: 3016674095 View Registration
• Schneider ASR B.V. Registration: 3016678045 View Registration
• Philips North America LLC Registration: 3016701404 View Registration
• LARK INDUSTRIES Registration: 3017060084 View Registration
• DT Research, Inc Taiwan Branch Registration: 3017233611 View Registration
• CATHVISION APS Registration: 3017401510 View Registration
• Itamar Medical Ltd. (Alon) Registration: 3017638059 View Registration
• VOLTA MEDICAL Registration: 3017684005 View Registration
• CARDIOCALM SRL Registration: 3017840980 View Registration
• COROVENTIS RESEARCH AB Registration: 3017845286 View Registration
• CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
• OXILINE LLC Registration: 3018940143 View Registration
• Masimo Corporation Registration: 3019388613 View Registration
• CARDIONXT Registration: 3020036682 View Registration
• VEKTOR MEDICAL, INC. Registration: 3021016555 View Registration
• iRhythm Technologies, Inc. Registration: 3021769057 View Registration
• Intelerad USA Registration: 3022435840 View Registration
• BIOSENSE WEBSTER, INC. Registration: 3022451073 View Registration
• CORDIANA MEDICAL INFORMATICS AG Registration: 3022780114 View Registration
• LEAD-LOK, INC. d.b.a Nissha Medical Technologies Registration: 3023164 View Registration
• CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
• ATsens Co., Ltd. Registration: 3024821700 View Registration
• RHYTHM AI INC Registration: 3026523691 View Registration
• TD SYNNEX Registration: 3026740087 View Registration
• IMPLICITY Registration: 3030125003 View Registration
• ICENTIA LLC Registration: 3030721635 View Registration
• B-SECUR LIMITED Registration: 3031786139 View Registration
• WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED Registration: 3032109181 View Registration
• BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration
• PHILIPS FRANCE Registration: 3033558564 View Registration
• Jaeger Medical America Inc. Registration: 3033959233 View Registration
• BENCHMARK ELECTRONICS San Jorge Registration: 3037724692 View Registration
• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175841 View Registration
• DREAMTECH VIETNAM CO., LTD Registration: 3043479346 View Registration
• CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
• SCHILLER AG Registration: 8030978 View Registration
• GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
• Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
• SPACELABS HEALTHCARE LTD. Registration: 9611295 View Registration
• Jaeger Medical GmbH Registration: 9615102 View Registration
• CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG Registration: 9615817 View Registration
• Change Healthcare Israel Ltd. Registration: 9616760 View Registration
• Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
• BIOSENSE WEBSTER, INC. Registration: 9673241 View Registration
• Nicolay GMBH Registration: 9681377 View Registration
• GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.