Dragonfly OpStar™ Imaging Catheter

• Boston Scientific Corporation Registration: 1000121056 View Registration
• AngioDynamics, Inc. Registration: 1000523114 View Registration
• Cordis US Corp. Registration: 1016427 View Registration
• C.R. BARD, INC. Registration: 1018233 View Registration
• Sterigenics U.S., LLC Registration: 1018470 View Registration
• OSCOR INC. Registration: 1035166 View Registration
• DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
• STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
• DeRoyal Industries, Inc. Registration: 1054241 View Registration
• DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
• Sterigenics US LLC Registration: 1058584 View Registration
• DeRoyal Industries, Inc. Registration: 1060680 View Registration
• Sterigenics U.S., LLC Registration: 1061124 View Registration
• INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
• STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
• MEDTRONIC VASCULAR Registration: 1220452 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
• HARMAC MEDICAL PRODUCTS, INC. Registration: 1317547 View Registration
• NUMED, INC. Registration: 1318694 View Registration
• ANGIODYNAMICS, INC. Registration: 1319211 View Registration
• Sterigenics U.S., LLC Registration: 1319639 View Registration
• MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
• MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
• MEDLINE INDUSTRIES, LP - SPT Registration: 1423395 View Registration
• Cardinal Health 200, LLC Registration: 1423537 View Registration
• ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
• ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
• BIOMERICS FMI Registration: 1646831 View Registration
• ICU MEDICAL, INC Registration: 1713468 View Registration
• MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
• Sterigenics U.S., LLC Registration: 1721676 View Registration
• Sterigenics U.S., LLC Registration: 1721686 View Registration
• Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
• Cook Incorporated Registration: 1820334 View Registration
• MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
• Sterigenics US LLC Registration: 2011171 View Registration
• Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
• ABBOTT VASCULAR Registration: 2024168 View Registration
• PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
• ICU MEDICAL, INC. Registration: 2025816 View Registration
• MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration
• Sterigenics U.S., LLC Registration: 2029275 View Registration
• Isomedix Operations, Inc. Registration: 2030624 View Registration
• Isomedix Operations, Inc Registration: 2032098 View Registration
• Isomedix Operations Inc. Registration: 2032112 View Registration
• Boston Scientific Corporation Registration: 2124215 View Registration
• INSITU TECHNOLOGIES, INC. Registration: 2134244 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
• VASCULAR SOLUTIONS LLC Registration: 2134812 View Registration
• Isomedix Operations, Inc. Registration: 2183744 View Registration
• Isomedix Operations Inc. Registration: 2246552 View Registration
• DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
• MEDICAL COMPONENTS INC Registration: 2518902 View Registration
• B. BRAUN MEDICAL INC. Registration: 2521402 View Registration
• B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration
• LYNX Medical Pennsylvania Registration: 2528981 View Registration
• EDWARDS LIFESCIENCES TECHNOLOGY SARL Registration: 2648045 View Registration
• CUSTOMED, INC. Registration: 2648727 View Registration
• Synergy Health Ireland Ltd Registration: 3002807314 View Registration
• SIPA Registration: 3002808466 View Registration
• Dimequip Registration: 3002808467 View Registration
• FCI FRANCE CHIRURGIE INSTRUMENTATION Registration: 3002991496 View Registration
• CD LEYCOM Registration: 3003493679 View Registration
• PARALLEL DESIGN SAS Registration: 3003594449 View Registration
• BIOCARDIA, INC. Registration: 3003610571 View Registration
• Biomerics Alajuela Registration: 3003678543 View Registration
• Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
• MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. Registration: 3003915875 View Registration
• Abbott Vascular Netherlands Registration: 3004091615 View Registration
• Sterigenics US LLC Registration: 3004111573 View Registration
• PRODUCTOS MEDLINE S.A. DE C.V. Registration: 3004122598 View Registration
• Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
• FCI SUD Registration: 3004467263 View Registration
• TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration
• DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration
• Cirtec Medical Registration: 3004737415 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration
• GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration
• MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
• ARROTEK MEDICAL LTD Registration: 3005255160 View Registration
• MEDLINE INDUSTRIES, LP - Laredo Registration: 3005595283 View Registration
• AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration
• Parker Industrial S de RL de CV Registration: 3005770916 View Registration
• Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
• C.R. BARD, INC. Registration: 3006082230 View Registration
• SEISA MEDICAL INC Registration: 3006131984 View Registration
• Arrow International C.R. a.s. Registration: 3006425876 View Registration
• ELCAM MEDICAL ACAL Registration: 3006891665 View Registration
• Merit Medical Nederland BV Registration: 3006950086 View Registration
• Siemens Healthineers Ltd. Registration: 3006985147 View Registration
• SHENZHEN ANTMED CO. LTD Registration: 3007048453 View Registration
• ALLWELL MEDICAL CORPORATION Registration: 3007138831 View Registration
• Medline Canada Registration: 3007289408 View Registration
• SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Registration: 3007361214 View Registration
• Cerenovus, Inc. Registration: 3007628272 View Registration
• ADVANCED LIFESCIENCES PVT. LTD. Registration: 3007830707 View Registration
• HOSMED INC. Registration: 3007836437 View Registration
• MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
• Curatia Medical Limited Registration: 3008261722 View Registration
• Cerenovus, Inc. Registration: 3008264254 View Registration
• Terumo Medical Canada, Inc. Registration: 3008307705 View Registration
• Volcano Corporation Registration: 3008363989 View Registration
• UNITRON GROUP BV Registration: 3008388260 View Registration
• CENTURION MEDICAL PRODUCTS, LP Registration: 3008403546 View Registration
• BIOXIN MEDICAL CO., LTD Registration: 3008496528 View Registration
• MedFact Engineering GmbH Registration: 3008497357 View Registration
• Edwards Lifesciences LLC Registration: 3008500478 View Registration
• GOALS STERILIZATION CO., LTD Registration: 3008573567 View Registration
• RM Healthcare Products SA de CV Registration: 3008692839 View Registration
• Verge Medical Inc. Registration: 3008700817 View Registration
• Stryker Neurovascular Registration: 3008853977 View Registration
• RESPICARDIA, INC. Registration: 3009144177 View Registration
• SIPV Registration: 3009291251 View Registration
• TERUMO CLINICAL SUPPLY CO., LTD. Registration: 3009500972 View Registration
• SCIENTIA VASCULAR Registration: 3009546466 View Registration
• Abbott Medical Registration: 3009600098 View Registration
• Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
• Isomedix Operations Inc Registration: 3009888344 View Registration
• EMERALD MEDICAL SERVICES PTE. LTD Registration: 3009965866 View Registration
• Teleflex LLC (NADC) Registration: 3010041511 View Registration
• MicroVention Costa Rica S.R.L. Registration: 3010079067 View Registration
• BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
• AvailMed S.A.De C.V. Registration: 3010291427 View Registration
• STERIS TOMOE SINGAPORE PTE LTD Registration: 3010421104 View Registration
• Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
• Arrow International, LLC (subsidiary of Teleflex, Incorporated) Registration: 3010532612 View Registration
• Merit Medical Systems, Inc. Registration: 3010665433 View Registration
• Surefire Medical, Inc. Registration: 3010909876 View Registration
• Cook Incorporated Registration: 3011050534 View Registration
• Teleflex Medical LLC Registration: 3011137372 View Registration
• Vygon Verneuil Registration: 3011237770 View Registration
• Medical Resale PTY Limited Registration: 3011416394 View Registration
• GENTUITY, LLC Registration: 3011578544 View Registration
• Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
• EMBOLX INC. Registration: 3011660785 View Registration
• MEDAS, INC. Registration: 3012050423 View Registration
• BIOMERICS Advanced Catheter Registration: 3012159165 View Registration
• St. Jude Medical Registration: 3012179728 View Registration
• Conavi Medical Inc Registration: 3012198618 View Registration
• PRYTIME MEDICAL DEVICES, INC. Registration: 3012279212 View Registration
• ICU Medical, Inc. Registration: 3012307300 View Registration
• SANICURE BV Registration: 3012494290 View Registration
• Stryker US Supply Chain Operations Registration: 3012497308 View Registration
• Merit Medical Canada Ltd. Registration: 3012536737 View Registration
• COOK, INC. Registration: 3012766489 View Registration
• Stryker Neurovascular Registration: 3012931345 View Registration
• HEXACATH Registration: 3013134719 View Registration
• Arrow International LLC (subsidiary of Teleflex Incorporated) Registration: 3013162291 View Registration
• ICU MEDICAL, INC. Registration: 3013319212 View Registration
• SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD. Registration: 3013351723 View Registration
• MicroVention, Inc. Registration: 3013556777 View Registration
• CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
• PHENOX LIMITED Registration: 3013656790 View Registration
• B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
• BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
• Medline International B.V. Registration: 3014499739 View Registration
• IMPERATIVE CARE INC. Registration: 3014590708 View Registration
• RHENUS SE & CO. KG Registration: 3014656749 View Registration
• Creganna Medical S. R. L Registration: 3014779787 View Registration
• Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
• Merit Medical Asia Company Limited Registration: 3015225571 View Registration
• Merit Medical UK Limited Registration: 3015309643 View Registration
• CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
• MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 3015550451 View Registration
• Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration
• Medline Industries (NAMIC Division) - Glen Falls Registration: 3015910259 View Registration
• CONOD MEDICAL SHUYANG CO., LTD. Registration: 3016171914 View Registration
• Schneider ASR B.V. Registration: 3016678045 View Registration
• CPE1, LLC DBA Greatbatch Medical Registration: 3017168767 View Registration
• VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
• Wuxi Goals Medical Technology Co., Ltd. Registration: 3017262662 View Registration
• CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
• PROCEDURE PRODUCTS, INC. Registration: 3020778 View Registration
• OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION) Registration: 3021343210 View Registration
• SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 3023245 View Registration
• Prytime Medical Devices, Inc. Registration: 3026788751 View Registration
• RCI HUDSON DE MEXICO S. DE RL. DE CV. Registration: 3029706818 View Registration
• MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L. Registration: 3029973819 View Registration
• PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
• PHARMCO MEDICAL BV Registration: 3030447506 View Registration
• SPECTRUM VASCULAR Registration: 3030714660 View Registration
• AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
• ENABLECV, LLC Registration: 3031571797 View Registration
• ADVANCED VASCULAR DYNAMICS Registration: 3032534 View Registration
• BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration
• Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
• LIQUET MEDICAL INC. Registration: 3038791046 View Registration
• ANTMED MALAYSIA SDN BHD Registration: 3042190142 View Registration
• TERUMO CORP. Registration: 8010026 View Registration
• Merit Medical Singapore Pte. Ltd. Registration: 8020616 View Registration
• VYGON S A Registration: 8020785 View Registration
• MICROTEK DOMINICANA, S.A.S. Registration: 8043817 View Registration
• Bioptimal International Pte. Ltd. Registration: 8043983 View Registration
• Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
• TOGO MEDIKIT CO., LTD. Registration: 9612126 View Registration
• ELCAM MEDICAL A.C.A.L. Registration: 9612152 View Registration
• FCI SAS Registration: 9615745 View Registration
• CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG Registration: 9615817 View Registration
• Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
• Cardinal Health Mexico 244 S de RL de CV Registration: 9616099 View Registration
• TELEFLEX MEDICAL Registration: 9616683 View Registration
• Boston Scientific Limited Registration: 9616684 View Registration
• ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration
• Medtronic Mexico S. de R.L. de CV Registration: 9617601 View Registration
• NUMED CANADA, INC. Registration: 9618000 View Registration
• Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
• Boston Scientific Limited Registration: 9681260 View Registration
• ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 View Registration
• GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration
• SEI Medical S.A. de C.V. Registration: 9710641 View Registration

Public Record Disclaimer

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.