Amplatzer Guidewire

• Boston Scientific Corporation Registration: 1000121056 View Registration
• COOK INCORPORATED Registration: 1000393132 View Registration
• AngioDynamics, Inc. Registration: 1000523114 View Registration
• Arrow International CR, a.s. Registration: 1000563940 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
• BIOTRONIK, INC. Registration: 1028232 View Registration
• MEDICAL ACTION INDUSTRIES, INC. 306 Registration: 1030451 View Registration
• DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
• AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 Registration: 1047429 View Registration
• STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
• DeRoyal Industries, Inc. Registration: 1054241 View Registration
• Sterigenics U.S. LLC Registration: 1054811 View Registration
• DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
• REMINGTON MEDICAL, INC. Registration: 1056553 View Registration
• Sterigenics U.S., LLC Registration: 1061124 View Registration
• ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
• TERUMO MEDICAL CORP. Registration: 1118880 View Registration
• STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
• MEDTRONIC VASCULAR Registration: 1220452 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
• GUIDEWIRE TECHNOLOGIES, INC. Registration: 1221806 View Registration
• ACME-MONACO CORP. Registration: 1222301 View Registration
• Vygon MFG Registration: 1223004 View Registration
• Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
• Cerenovus, Inc. Registration: 1226348 View Registration
• Covidien LLC Registration: 1282497 View Registration
• ACME-MONACO CORP. Registration: 1293141 View Registration
• C.R. BARD, INC. Registration: 1313046 View Registration
• ANGIODYNAMICS, INC. Registration: 1319211 View Registration
• Sterigenics U.S., LLC Registration: 1319639 View Registration
• ARGON MEDICAL DEVICES, INC. Registration: 1417485 View Registration
• MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
• Cardinal Health 200, LLC Registration: 1423537 View Registration
• Isomedix Operations, Inc. Registration: 1450662 View Registration
• ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
• MedXL Registration: 1644312 View Registration
• GALT MEDICAL CORP. Registration: 1649395 View Registration
• TORAY INTERNATIONAL AMERICA INC. Registration: 1649869 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1720929 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
• CENTURION MEDICAL PRODUCTS, LP Registration: 1824619 View Registration
• MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
• Sterigenics US LLC Registration: 2011171 View Registration
• ABBOTT MEDICAL Registration: 2017865 View Registration
• BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
• Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
• ABBOTT VASCULAR Registration: 2024168 View Registration
• PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
• Medtronic Heart Valves Division Registration: 2025587 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
• Boston Scientific Corporation Registration: 2124215 View Registration
• Lake Region Medical Registration: 2126666 View Registration
• Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
• INSITU TECHNOLOGIES, INC. Registration: 2134244 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
• RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
• VASCULAR SOLUTIONS LLC Registration: 2134812 View Registration
• Abbott Medical Registration: 2135147 View Registration
• MEDTRONIC, INC. Registration: 2182208 View Registration
• St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration
• Isomedix Operations, Inc. Registration: 2183744 View Registration
• Medtronic, Inc. Registration: 2183870 View Registration
• St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2184149 View Registration
• Sterigenics U.S., LLC Registration: 2219920 View Registration
• VYGON USA Registration: 2245270 View Registration
• Datascope Corp. Registration: 2248146 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
• MARTECH MEDICAL PRODUCTS Registration: 2527072 View Registration
• LYNX Medical Pennsylvania Registration: 2528981 View Registration
• VOLCANO CORPORATION Registration: 2939520 View Registration
• ABBOTT VASCULAR Registration: 2939561 View Registration
• Medtronic Vascular Registration: 2953200 View Registration
• Philips Electronics Ltd Registration: 3000126629 View Registration
• NIPRO CORPORATION Registration: 3000247873 View Registration
• IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration
• INNOPEX LIMITED Registration: 3001124136 View Registration
• TORAY MEDICAL CO., LTD. Registration: 3002244583 View Registration
• Synergy Health Ireland Ltd Registration: 3002807314 View Registration
• WILLIAM COOK EUROPE APS Registration: 3002808486 View Registration
• PIOLAX MEDICAL DEVICES, INC. Registration: 3002917664 View Registration
• STEREOTAXIS, INC. Registration: 3003084417 View Registration
• EPFLEX FEINWERKTECHNIK GMBH Registration: 3003289691 View Registration
• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
• ASAHI INTECC CO., LTD. Registration: 3003775027 View Registration
• ASAHI INTECC (THAILAND) CO., LTD. Registration: 3003780911 View Registration
• GYRUS ACMI, INC. Registration: 3003790304 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
• Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 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
• SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration
• STERIS AST CZ s.r.o. Registration: 3004784537 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration
• MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
• St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
• COOK MEDICAL LLC Registration: 3005580113 View Registration
• ABBOTT VASCULAR Registration: 3005737652 View Registration
• Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
• BRIVANT, LTD. Registration: 3006010712 View Registration
• C.R. BARD, INC. Registration: 3006082230 View Registration
• NeedleTech Products, Inc. Registration: 3006283319 View Registration
• Arrow International C.R. a.s. Registration: 3006425876 View Registration
• CEA Global Dominicana d.b.a. Nissha Medical Technologies Registration: 3006891611 View Registration
• MEDISTRI SA Registration: 3006946276 View Registration
• Merit Medical Nederland BV Registration: 3006950086 View Registration
• Acme Monaco Asia Pte. Ltd. Registration: 3007064586 View Registration
• Abbott Medical Registration: 3007113487 View Registration
• ALLWELL MEDICAL CORPORATION Registration: 3007138831 View Registration
• MERMAID MEDICAL A/S Registration: 3007146453 View Registration
• SPECTRANETICS CORP. Registration: 3007284006 View Registration
• SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Registration: 3007361214 View Registration
• Cerenovus, Inc. Registration: 3007628272 View Registration
• Confluent Medical Technologies, Inc Registration: 3007635982 View Registration
• Boston Scientific Corporation Registration: 3007695959 View Registration
• Synergy Health AST, SRL Registration: 3007738736 View Registration
• ADVANCED LIFESCIENCES PVT. LTD. Registration: 3007830707 View Registration
• LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Registration: 3008002401 View Registration
• OPSENS INC. Registration: 3008061490 View Registration
• MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
• Cerenovus, Inc. Registration: 3008264254 View Registration
• Terumo Medical Canada, Inc. Registration: 3008307705 View Registration
• Volcano Corporation Registration: 3008363989 View Registration
• CENTURION MEDICAL PRODUCTS, LP Registration: 3008403546 View Registration
• STRAUB MEDICAL AG Registration: 3008439199 View Registration
• I-Tek Medical, Inc. Registration: 3008627763 View Registration
• STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
• Stryker Neurovascular Registration: 3008853977 View Registration
• HERAEUS MEDICAL COMPONENTS, LLC Registration: 3008988055 View Registration
• Nitinol Devices & Components Costa Rica, S. R. L. Registration: 3009018440 View Registration
• HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration
• Yokowo Co., Ltd Registration: 3009092139 View Registration
• ASAHI INTECC HANOI CO., LTD. Registration: 3009121749 View Registration
• Cardinal Health Costa Rica, S.A. Registration: 3009211636 View Registration
• Medtronic Distribution Center Registration: 3009380063 View Registration
• Volcano Corporation by Volcarica S.R.L. Registration: 3009490946 View Registration
• Cook Medical EUDC GmbH Registration: 3009526575 View Registration
• SCIENTIA VASCULAR Registration: 3009546466 View Registration
• Abbott Vascular Registration: 3009564766 View Registration
• Abbott Medical Registration: 3009600098 View Registration
• ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
• Isomedix Operations Inc Registration: 3009888344 View Registration
• RAPID-MEDICAL LTD Registration: 3009957947 View Registration
• Teleflex LLC (NADC) Registration: 3010041511 View Registration
• BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
• Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
• APPLIMED SA -CSSR Registration: 3010163695 View Registration
• Synergy Health AST, SRL Registration: 3010273872 View Registration
• AvailMed S.A.De C.V. Registration: 3010291427 View Registration
• SIGNA MEDICAL, INC. Registration: 3010419931 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
• HEALTH LINE INTERNATIONAL CORPORATION Registration: 3010882065 View Registration
• Gyrus ACMI, Inc. Registration: 3011050570 View Registration
• Teleflex Medical LLC Registration: 3011137372 View Registration
• Beijing Target Medical Technologies Inc. Registration: 3011564431 View Registration
• ATRICURE, INC. Registration: 3011706110 View Registration
• MEDAS, INC. Registration: 3012050423 View Registration
• CENTERLINE BIOMEDICAL Registration: 3012154226 View Registration
• BIOMERICS Advanced Catheter Registration: 3012159165 View Registration
• St. Jude Medical Registration: 3012179728 View Registration
• FILMECC CO., LTD. Registration: 3012223769 View Registration
• Stryker US Supply Chain Operations Registration: 3012497308 View Registration
• Merit Medical Canada Ltd. Registration: 3012536737 View Registration
• Stryker Neurovascular Registration: 3012931345 View Registration
• FMD. Co., Ltd. Registration: 3013023134 View Registration
• Arrow International LLC (subsidiary of Teleflex Incorporated) Registration: 3013162291 View Registration
• ABBOTT MEDICAL Registration: 3013288201 View Registration
• MicroVention, Inc. Registration: 3013556777 View Registration
• CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
• NANO4IMAGING GMBH Registration: 3013595987 View Registration
• Terumo Yamaguchi Corporation Registration: 3013611763 View Registration
• PHENOX LIMITED Registration: 3013656790 View Registration
• Heraeus Medical Components, SRL Registration: 3013666336 View Registration
• Medical Components, Inc. Registration: 3013750125 View Registration
• B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
• Zurich Medical Inc Registration: 3013943846 View Registration
• BALT USA, LLC Registration: 3014162263 View Registration
• Boston Scientific Medical Device (Malaysia) SDN BHD Registration: 3014222368 View Registration
• Biomerics Cartago Registration: 3014246639 View Registration
• MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
• BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
• Medline International B.V. Registration: 3014499739 View Registration
• WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
• IMPERATIVE CARE INC. Registration: 3014590708 View Registration
• RHENUS SE & CO. KG Registration: 3014656749 View Registration
• FLAT MEDICAL CO., LTD. Registration: 3014716786 View Registration
• FMD Co., Ltd. Okinawa Factory Registration: 3014977413 View Registration
• CARDIO FLOW, INC. Registration: 3015124694 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
• C2Dx, Inc. Registration: 3015489752 View Registration
• NANO4IMAGING USA, LLC. Registration: 3015522130 View Registration
• RAPID MEDICAL INC. Registration: 3015531723 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
• Toyoflex Cebu Corporation Registration: 3016119728 View Registration
• Schneider ASR B.V. Registration: 3016678045 View Registration
• VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
• STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
• SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD. Registration: 3017961114 View Registration
• SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD. Registration: 3018070217 View Registration
• BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. Registration: 3018784828 View Registration
• Boston Scientific Corporation Registration: 3019751610 View Registration
• MEHOW INNOVATIVE (HUIZHOU) LTD. Registration: 3020283264 View Registration
• PROCEDURE PRODUCTS, INC. Registration: 3020778 View Registration
• AtriCure, Inc. Registration: 3020954746 View Registration
• BAYLIS MEDICAL TECHNOLOGIES INC. Registration: 3020968442 View Registration
• SUREAX MEDICAL, CORPORATION Registration: 3024682301 View Registration
• EMBRACE MEDICAL LTD. Registration: 3024743081 View Registration
• DEEPINTEC SCIENTIFIC CO., LTD Registration: 3026317086 View Registration
• Mermaid Medical A/S (FL Site) Registration: 3027260597 View Registration
• PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
• PHARMCO MEDICAL BV Registration: 3030447506 View Registration
• ARTIRIA MEDICAL SA Registration: 3030452144 View Registration
• MOZARC MEDICAL US LLC Registration: 3030574705 View Registration
• AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
• Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
• SOLO PACE INC Registration: 3035372913 View Registration
• Honduras Kitting, S.A. Registration: 3035642068 View Registration
• Theragenics Costa Rica Limitada Registration: 3036802499 View Registration
• ARBOR ENDOVASCULAR Registration: 3039642752 View Registration
• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175841 View Registration
• TERUMO CORP. Registration: 8010026 View Registration
• BALT EXTRUSION Registration: 8023054 View Registration
• BIOTRONIK AG Registration: 8043892 View Registration
• BIOTRONIK SE & CO. KG Registration: 9610139 View Registration
• Covidien Registration: 9610849 View Registration
• NIPRO MEDICAL INDUSTRIES LTD. Registration: 9611446 View Registration
• Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
• TORAY INDUSTRIES, INC. SETA PLANT Registration: 9612812 View Registration
• B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration
• TORAY INDUSTRIES, INC. Registration: 9614758 View Registration
• Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
• MERIT MEDICAL IRELAND, LTD Registration: 9616662 View Registration
• Boston Scientific Limited Registration: 9616684 View Registration
• BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
• Venusa de Mexico S. de R.L de C.V Registration: 9680001 View Registration
• Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
• Boston Scientific Limited Registration: 9681260 View Registration
• LAKE REGION MEDICAL LIMITED Registration: 9681477 View Registration
• ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 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.