| Accoat Guide Wire (K253667) | Sp Medical A/S | 2026-07-14 |
| Merit MAK Nitinol/Gold-Tungsten Guide Wire (K261640) | Merit Medical Ireland , Ltd. | 2026-07-13 |
| InQwire Amplatz Guide Wire (K254137) | Merit Medical Ireland, Ltd. | 2026-05-22 |
| FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (K260544) | FMD Co., Ltd. | 2026-03-20 |
| Enroute 0.014'' Transcarotid Guidewire (K253746) | Lake Region Medical | 2026-03-19 |
| EmeryGlide™ (EG18008901) (K253262) | Nano4imaging GmbH | 2026-03-06 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (K253847) | Merit Medical Ireland, Ltd. | 2026-01-31 |
| InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) (K251385) | Merit Medical Ireland, Ltd. | 2026-01-21 |
| Solo Pace Fusion System (SOLOFUSE1) (K252674) | Solo Pace, Inc. | 2026-01-09 |
| Lunderquist Extra Stiff Wire Guide (K251596) | William Cook Europe Aps | 2025-11-09 |
| SureAx-Guide™ (K250203) | Sureax Medical, LLC | 2025-10-17 |
| Amplatzer Guidewire (K250031) | ABBOTT MEDICAL | 2025-10-03 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) (K251181) | Merit Medical Ireland, Ltd. | 2025-08-29 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552) | ABBOTT MEDICAL | 2025-07-25 |
| Medtronic Stedi Extra Support Guidewire (K250075) | Medtronic, Inc. | 2025-06-13 |
| SION blue PLUS (K243733) | Asahi Intecc Co., Ltd. | 2025-04-02 |
| Crossloop (K241962) | Asahi Intecc Co., Ltd. | 2025-03-27 |
| CROSSLEAD 0.018inch (K242597) | Asahi Intecc Co., Ltd. | 2025-03-05 |
| CROSSLEAD 0.014inch (K241702) | Asahi Intecc Co., Ltd. | 2025-02-06 |
| Prelude Small O.D. Introducer Guide Wire (K241521) | Merit Medical Systems, Inc. | 2024-12-10 |
| PTFE Guidewire (K242824) | Lake Region Medical | 2024-12-06 |
| R2P Radifocus Glidewire Advantage (K240818) | Terumo Corporation | 2024-11-26 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) | ABBOTT MEDICAL | 2024-11-06 |
| Arrow® Nitinol Wire (K241784) | Teleflex Medical | 2024-09-18 |
| Glidewire GT-R (K240859) | Terumo Corporation | 2024-08-21 |
| CROSSLEAD Tracker (K241510) | Asahi Intecc Co., Ltd. | 2024-08-14 |
| MINAMO blue; MINAMO viola (K240387) | Asahi Intecc Co., Ltd. | 2024-06-21 |
| FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) (K240460) | FMD Co., Ltd. | 2024-06-13 |
| PacePro Wire (K240864) | Opsens, Inc. | 2024-05-24 |
| BNLE Hydrophilic Jacketed Peripheral Guidewire (K232662) | Biomerics Nle | 2024-05-14 |
| Mighty Wire Guide Wire (K230418) | Merit Medical Systems, Inc. | 2023-10-28 |
| Steerant™ Super Stiff Guidewire (K232570) | Medtronic Vascular | 2023-10-24 |
| VASSALLO GT Crossing14 (K232574) | Filmec Co. , Ltd. | 2023-10-11 |
| VASSALLO GT 018 G12; VASSALLO GT 018 G30 (K232578) | Filmec Co. , Ltd. | 2023-10-11 |
| CROSSLEAD Penetration Peripheral Guide Wire (K230377) | Asahi Intecc Co., Ltd. | 2023-07-20 |
| TalWire (K223791) | Embrace Medical , Ltd. | 2023-07-14 |
| Wattson temporary pacing guidewire (2250) (K230637) | Vascular Solutions, LLC | 2023-05-05 |
| BNLE Access Guidewire (K221390) | Biomerics Nle | 2023-04-28 |
| Vassallo GT 018 Hybrid (K223432) | Filmecc Co., Ltd. | 2023-03-09 |
| ProTrack Pigtail Wire (K213898) | Baylis Medical Company, Inc. | 2023-03-01 |
| Mechanical Guidewire (K221351) | Baylis Medical Company, Inc. | 2022-12-19 |
| VASSALLO GT EXT (K222631) | Filmecc Co., Ltd. | 2022-10-26 |
| Pre-Formed Blue (K221575) | Lake Region Medical | 2022-10-07 |
| EpiFaith CV (K212615) | Flat Medical Co., Ltd. | 2022-09-21 |
| SavvyWire (K213854) | Opsens, Inc. | 2022-09-14 |
| ASAHI Gladius Mongo18 PV ES (K213868) | Asahi Intecc Co., Ltd. | 2022-09-06 |
| Stent Positioning Assistance System (SPAS) (K221917) | Seven Sons , Ltd. | 2022-08-19 |
| CROSSLEAD Peripheral Guide Wire (K213315) | Asahi Intecc Co., Ltd. | 2022-07-01 |
| VASSALLO GT 018 Floppy (K213949) | Filmecc Co., Ltd. | 2022-06-30 |
| FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (K212268) | FMD Co., Ltd. | 2022-05-27 |
| Medline Integrated Arterial Catheter (K210548) | Centurion Medical Products | 2022-05-17 |
| Spartan Center Wire (K220075) | Spartan Micro, Inc. | 2022-04-19 |
| Cardio Flow Peripheral Guide Wire (K213834) | Cardio Flow Inc., | 2022-03-18 |
| Lunderquist Extra Stiff Wire Guide (K220137) | William Cook Europe Aps | 2022-02-17 |
| R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (K212167) | Vascular Solutions, LLC | 2022-02-09 |
| ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (K211898) | Asahi Intecc Co., Ltd. | 2021-12-08 |
| Pre-Formed Extra Support Guidewire (K211741) | Lake Region Medical | 2021-11-22 |
| VASSALLO GT Hybrid (K203529) | Filmecc Co., Ltd. | 2021-05-04 |
| VASSALLO GT (K203533) | Filmecc Co., Ltd. | 2021-04-21 |
| Verrata PLUS Pressure Guide Wire (K210235) | Volcano Corporation | 2021-04-15 |
| LiPPS Analyzer, LiPPS Wire Pressure Guide Wire (K201720) | Beijing Bywave Sensing Medical Technology Co., Ltd. | 2021-02-18 |
| Merit Hydrophilic Guide Wire (K201595) | Merit Medical Systems, Inc. | 2020-10-14 |
| OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543) | Volcano Corporation | 2020-09-28 |
| Hydrophilic Coating Guide Wire (K193653) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-08-26 |
| HI-TORQUE PROCEED Guide Wire Family (K201834) | Abbott Vascular | 2020-07-30 |
| Zoom 14 Guidewire (K201760) | Scientia Vascular, LLC | 2020-07-29 |
| Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (K201690) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 |
| LiteSaber Wire Torque Assist Device (K200120) | Vesatek, LLC | 2020-05-07 |
| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
| Go2Wire Guide Wire (K193571) | Merit Medical System, Inc. | 2020-04-08 |
| OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K192886) | Volcano Corporation | 2020-03-26 |
| Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire (K193548) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-01-18 |
| Wattson Temporary Pacing Guidewire (K192454) | Vascular Solutions | 2020-01-15 |
| ASAHI PTCA Guide Wire ASAHI Gaia Next (K192599) | Asahi Intecc Co., Ltd. | 2020-01-02 |
| OptoWire III (K191907) | Opsens, Inc. | 2020-01-02 |
| CrossTorq 14 Guidewire (K193194) | Scientia Cardio Access, LLC | 2019-12-13 |
| HI-TORQUE InfilTrac Guide Wire Family (K193126) | Abbott Vascular | 2019-12-11 |
| Heraeus Peripheral Guidewire (K191502) | Heraeus Medical Components, LLC | 2019-11-26 |
| Asahi PTCA Guide Wire Asahi SION Series (K191464) | Asahi Intecc Co., Ltd. | 2019-11-21 |
| Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile (K192783) | Scientia Vascular, LLC | 2019-10-30 |
| pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (K191687) | Phenox Limited | 2019-10-09 |
| MINAMO (K190176) | Asahi Intecc Co., Ltd. | 2019-08-01 |
| Roadrunner PC Wire Guide, Olcott Torque Device (K182985) | Cook Incorporated | 2019-07-22 |
| ASAHI Silverway (K183062) | Asahi Intecc Co., Ltd. | 2019-07-01 |
| Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J (K182457) | Brivant Limited (Lake Region Medical) | 2019-04-18 |
| Inno-Pathwire (K182553) | Suzhou Innomed Medical Device Co., Ltd. | 2019-03-11 |
| Lunderquist® Fixed Core Wire Guide (K181353) | Cook Incorporated | 2019-02-15 |
| Roadrunner Extra Support Wire Guide (K183467) | Cook Incorporated | 2019-01-11 |
| Reuter Tip Deflecting Wire Guide (K180830) | Cook Incorporated | 2018-12-20 |
| Magic Torque DLVR Guidewire (K182315) | Boston Scientific Corporation | 2018-09-26 |
| Bandit guidewire (K181647) | Vascular Solutions, Inc. | 2018-07-20 |
| ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES (K180784) | Asahi Intecc Co., Ltd. | 2018-07-18 |
| ASAHI PTCA Guide Wire ASAHI SION black (K173277) | Asahi Intecc Co., Ltd. | 2018-07-05 |
| Savion DLVR Guidewire, Savion FLX Guidewire (K180726) | Boston Scientific, Inc. | 2018-06-18 |
| Double Flexible Tipped Wire Guides (K181351) | Cook Incorporated | 2018-06-14 |
| Medtronic Confida Brecker Guidewire (K181001) | Medtronic Core Valve, LLC | 2018-05-03 |
| JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire (K180795) | Boston Scientific | 2018-04-12 |
| Inno-Hydrowire (K172187) | Suzhou Innomed Medical Device Co., Ltd. | 2018-04-11 |
| Mandril Wire Guide (K171997) | Cook Incorporated | 2018-03-30 |
| Double Flexible Tip Wire Guides (K171912) | Cook Incorporated | 2018-03-19 |