ALLIGATOR RETRIEVAL DEVICE (ARD)

• Boston Scientific Corporation Registration: 1000121056 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
• ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
• STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
• Sterigenics US LLC Registration: 1058584 View Registration
• Sterigenics U.S., LLC Registration: 1061124 View Registration
• INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 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
• Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
• C.R. BARD, INC. Registration: 1313046 View Registration
• NUMED, INC. Registration: 1318694 View Registration
• Sterigenics U.S., LLC Registration: 1319639 View Registration
• Isomedix Operations, Inc. Registration: 1450662 View Registration
• Sterigenics US, LLC Registration: 1526534 View Registration
• ICU Medical, Inc. Registration: 1526863 View Registration
• NORMAN NOBLE, INC. Registration: 1531050 View Registration
• ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
• ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
• BIOMERICS FMI Registration: 1646831 View Registration
• Steritec Services, LLC Registration: 1647149 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
• MEDRON, LLC Registration: 1722746 View Registration
• Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
• Cook Incorporated Registration: 1820334 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 1828132 View Registration
• MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
• Sterigenics US LLC Registration: 2011171 View Registration
• W. L. GORE & ASSOCIATES, INC Registration: 2017233 View Registration
• ABBOTT MEDICAL Registration: 2017865 View Registration
• BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
• AXIOM MEDICAL, INC. Registration: 2020735 View Registration
• Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
• ABBOTT VASCULAR Registration: 2024168 View Registration
• PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
• BREVET INC. Registration: 2025870 View Registration
• BIOSEAL Registration: 2027062 View Registration
• APPLIED MEDICAL RESOURCES CORP. Registration: 2027111 View Registration
• MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration
• Sterigenics U.S., LLC Registration: 2029275 View Registration
• Synergy Health AST, LLC Registration: 2030598 View Registration
• Isomedix Operations, Inc. Registration: 2030624 View Registration
• Isomedix Operations Inc. Registration: 2032112 View Registration
• Boston Scientific Corporation Registration: 2124215 View Registration
• Lake Region Medical Registration: 2126666 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 2134265 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
• Greatbatch Medical Registration: 2183787 View Registration
• Medtronic, Inc. Registration: 2183870 View Registration
• MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 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
• Boston Scientific Corporation Registration: 2648729 View Registration
• MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 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
• FUJI SYSTEMS CORPORATION, Shirakawa Plant Registration: 3000308637 View Registration
• INNOPEX LIMITED Registration: 3001124136 View Registration
• SURMODICS, INC. Registration: 3001374820 View Registration
• STERIS SPA Registration: 3002806603 View Registration
• Sterigenics Germany GmbH Registration: 3002807090 View Registration
• Synergy Health Ireland Ltd Registration: 3002807314 View Registration
• BIOCARDIA, INC. Registration: 3003610571 View Registration
• ASAHI INTECC CO., LTD. Registration: 3003775027 View Registration
• OrbusNeich Medical (Shenzhen) Co., Ltd. Registration: 3003775186 View Registration
• ASAHI INTECC (THAILAND) CO., LTD. Registration: 3003780911 View Registration
• Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
• W. L. GORE & ASSOCIATES, INC. Registration: 3003910212 View Registration
• MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. Registration: 3003915875 View Registration
• Medtronic Grand Rapids Registration: 3003955307 View Registration
• Lake Region Medical Registration: 3004063494 View Registration
• Abbott Vascular Netherlands Registration: 3004091615 View Registration
• Sterigenics US LLC Registration: 3004111573 View Registration
• NATEC MEDICAL LTD Registration: 3004415014 View Registration
• ASAHI INTECC USA, INC. Registration: 3004718255 View Registration
• Cardiovascular Systems Incorporated Registration: 3004742232 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
• Abbott Vascular Registration: 3005070406 View Registration
• PENUMBRA, INC. Registration: 3005168196 View Registration
• Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
• Teleflex Medical OEM LLC Registration: 3005232773 View Registration
• ARROTEK MEDICAL LTD Registration: 3005255160 View Registration
• St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
• COOK MEDICAL LLC Registration: 3005580113 View Registration
• PENDRACARE INTERNATIONAL B.V. Registration: 3005635992 View Registration
• ABBOTT VASCULAR Registration: 3005718570 View Registration
• Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
• Creagh Medical Ltd. Registration: 3005994106 View Registration
• C.R. BARD, INC. Registration: 3006082230 View Registration
• SEISA MEDICAL INC Registration: 3006131984 View Registration
• Bard Access Systems, Inc. Registration: 3006260740 View Registration
• Arrow International C.R. a.s. Registration: 3006425876 View Registration
• Covidien Medical Products (Shanghai) Manufacturing LLC Registration: 3006451981 View Registration
• NATEC MEDICAL LTD (Maurister) Registration: 3006550224 View Registration
• HAOLANG TECHNOLOGY (FOSHAN) LIMITED CORPORATION Registration: 3006942602 View Registration
• MEDISTRI SA Registration: 3006946276 View Registration
• Merit Medical Nederland BV Registration: 3006950086 View Registration
• Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
• Abbott Medical Registration: 3007113487 View Registration
• NEO MEDICAL INC. Registration: 3007207906 View Registration
• SPECTRANETICS CORP. Registration: 3007284006 View Registration
• W. L. GORE & ASSOCIATES, INC. Registration: 3007284313 View Registration
• Cerenovus, Inc. Registration: 3007628272 View Registration
• Synergy Health AST, SRL Registration: 3007738736 View Registration
• IMDS Operations B.V. Registration: 3007740583 View Registration
• Greatbatch Medical, S. de R.L. de C.V. Registration: 3007882731 View Registration
• MARVAO MEDICAL DEVICES LTD. Registration: 3008110587 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
• Curatia Medical Co. Registration: 3008361782 View Registration
• LIFETECH SCIENTIFIC (SHENZHEN) CO,.LTD Registration: 3008423561 View Registration
• GOALS STERILIZATION CO., LTD Registration: 3008573567 View Registration
• I-Tek Medical, Inc. Registration: 3008627763 View Registration
• Verge Medical Inc. Registration: 3008700817 View Registration
• REFLOW MEDICAL, INC Registration: 3008789872 View Registration
• CARDIOVASCULAR SYSTEMS INCORPORATED Registration: 3008814558 View Registration
• STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
• STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
• Stryker Neurovascular Registration: 3008853977 View Registration
• Stryker Neurovascular Registration: 3008881809 View Registration
• Nitinol Devices & Components Costa Rica, S. R. L. Registration: 3009018440 View Registration
• Applied Medical Distribution Center Registration: 3009051888 View Registration
• ASAHI INTECC HANOI CO., LTD. Registration: 3009121749 View Registration
• RESPICARDIA, INC. Registration: 3009144177 View Registration
• Medtronic Distribution Center Registration: 3009380063 View Registration
• SCIENTIA VASCULAR Registration: 3009546466 View Registration
• Abbott Vascular Registration: 3009564766 View Registration
• ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
• Synergy Health Ede BV Registration: 3009756327 View Registration
• QXMEDICAL, LLC Registration: 3009766315 View Registration
• Isomedix Operations Inc Registration: 3009888344 View Registration
• BLUE LINE STERILIZATION SERVICES Registration: 3009905888 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
• Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
• Synergy Health Westport Ltd Registration: 3010173425 View Registration
• Synergy Health AST, SRL Registration: 3010273872 View Registration
• AvailMed S.A.De C.V. Registration: 3010291427 View Registration
• STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD Registration: 3010370269 View Registration
• SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
• STERIS TOMOE SINGAPORE PTE LTD Registration: 3010421104 View Registration
• Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
• Merit Medical Systems, Inc. Registration: 3010665433 View Registration
• HEALTH LINE INTERNATIONAL CORPORATION Registration: 3010882065 View Registration
• Surefire Medical, Inc. Registration: 3010909876 View Registration
• CYDONIA PHARMA SL Registration: 3011088743 View Registration
• Teleflex Medical LLC Registration: 3011137372 View Registration
• Rontis Hellas S.A. Registration: 3011142981 View Registration
• ATRICURE, INC. Registration: 3011706110 View Registration
• MEDAS, INC. Registration: 3012050423 View Registration
• Synergy Health AST, LLC Registration: 3012102437 View Registration
• CENTERLINE BIOMEDICAL Registration: 3012154226 View Registration
• BIOMERICS Advanced Catheter Registration: 3012159165 View Registration
• St. Jude Medical Registration: 3012179728 View Registration
• Resolution Medical Registration: 3012266672 View Registration
• PRYTIME MEDICAL DEVICES, INC. Registration: 3012279212 View Registration
• ICU Medical, Inc. Registration: 3012307300 View Registration
• STERI-TEK Registration: 3012448339 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
• WALLABY MEDICAL Registration: 3012543881 View Registration
• Stryker Neurovascular Registration: 3012931345 View Registration
• HEXACATH Registration: 3013134719 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
• Penumbra Inc. Registration: 3013758550 View Registration
• B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
• M4D LLC Registration: 3013858269 View Registration
• Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration
• BALT USA, LLC Registration: 3014162263 View Registration
• ALEMBIC LLC Registration: 3014211783 View Registration
• BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
• VESALIO Registration: 3014498720 View Registration
• WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
• IMPERATIVE CARE INC. Registration: 3014590708 View Registration
• Shanghai Wallaby Medical Technologies CO., Inc. Registration: 3014644549 View Registration
• RHENUS SE & CO. KG Registration: 3014656749 View Registration
• SURMODICS, INC. Registration: 3014687026 View Registration
• FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant Registration: 3014766734 View Registration
• Creganna Medical S. R. L Registration: 3014779787 View Registration
• ORBUSNEICH MEDICAL CO. LTD (HONG KONG) Registration: 3015002281 View Registration
• SHOCKWAVE MEDICAL, INC. Registration: 3015053858 View Registration
• MERAQI MEDICAL, INC. Registration: 3015060261 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
• Penumbra Inc. Registration: 3015615738 View Registration
• Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration
• CENTERPOINT SYSTEMS LLC Registration: 3015970743 View Registration
• Toyoflex Cebu Corporation Registration: 3016119728 View Registration
• PROVISIO MEDICAL INC. Registration: 3016171942 View Registration
• Okami Medical Inc. Registration: 3016444913 View Registration
• Route 92 Medical, Head Quarters Registration: 3016522967 View Registration
• NeuroVasc Technologies, Inc. Registration: 3016540856 View Registration
• Penumbra Inc. Registration: 3016591327 View Registration
• Schneider ASR B.V. Registration: 3016678045 View Registration
• CATHX MEDICAL INC Registration: 3016704395 View Registration
• HAOLANG MEDICAL USA CORPORATION Registration: 3016727301 View Registration
• BMC MEDICAL MANUFACTURING S.A. DE C.V. Registration: 3016829855 View Registration
• TRANSIT SCIENTIFIC, LLC Registration: 3016948450 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
• BEND IT TECHNOLOGIES LTD. Registration: 3017278832 View Registration
• SEIGLA MEDICAL, INC. Registration: 3017708755 View Registration
• Boston Scientific Corporation Registration: 3019751610 View Registration
• CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
• Inari Medical, Inc. Registration: 3020347218 View Registration
• Elumn8 Medical, Inc Registration: 3020677060 View Registration
• Abbott Medical Registration: 3020950818 View Registration
• Q'apel Medical, Inc. Registration: 3020954126 View Registration
• AtriCure, Inc. Registration: 3020954746 View Registration
• QUASAR MEDICAL (SINGAPORE) PTE. LTD. Registration: 3021951050 View Registration
• SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CORPORATION LIMITED Registration: 3024801436 View Registration
• EOSOLUTIONS, CORP. Registration: 3025028711 View Registration
• BOSTON SCIENTIFIC CORPORATION Registration: 3025341484 View Registration
• Prytime Medical Devices, Inc. Registration: 3026788751 View Registration
• Reflow Medical Registration: 3027058844 View Registration
• MADURO MEDICAL, INC. Registration: 3027319104 View Registration
• DK Medical Technology Co., Ltd. Registration: 3027343398 View Registration
• Route 92 Medical, West Jordan Registration: 3030088112 View Registration
• Teleflex LLC Registration: 3030236028 View Registration
• AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
• TORO NEUROVASCULAR, INC. Registration: 3031311812 View Registration
• PIRAEUS MEDICAL, INC. Registration: 3031768596 View Registration
• CROSSROADS NEUROVASCULAR Registration: 3032047719 View Registration
• VANTIS VASCULAR, INC. Registration: 3032277090 View Registration
• BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration
• Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
• GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration
• BASIS MEDICAL Registration: 3038912532 View Registration
• CORVITEX CORPORATION Registration: 3039062605 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
• MEDTRONIC IRELAND Registration: 9612164 View Registration
• Kaneka Corporation Osaka Plant Registration: 9614654 View Registration
• Cardinal Health Mexico 244 S de RL de CV Registration: 9616099 View Registration
• CLEARSTREAM TECHNOLOGIES LTD. Registration: 9616666 View Registration
• Boston Scientific Limited Registration: 9616684 View Registration
• BARD REYNOSA S.A. DE C.V. Registration: 9617592 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
• LAKE REGION MEDICAL LIMITED Registration: 9681477 View Registration
• ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 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.