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ABBOTT MEDICAL

FDA 510(k) & PMA Approved 器材 — 60 products

器材總數60
類別0
最新 FDA 裁決
類型編號器材名稱代碼日期操作
510(k) K261729 EnSite™ X EP SystemDQK2026-09-17 查看
510(k) K262006 EnSite™ X EP SystemDQK2026-07-15 查看
510(k) K261631 Amplatzer TorqVue 交換系統DQY2026-06-17 查看
510(k) K253459 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)NQQ2026-04-24 查看
510(k) K260212 EnSite™ X EP SystemDQK2026-04-20 查看
510(k) K253907 Disposable Radiofrequency CannulaGXI2026-04-16 查看
510(k) K260499 Amplatzer™ Trevisio™ 頸內血管遞送系統; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13 查看
510(k) K252512 Armada™ 14 NC PTA 穿刺導管LIT2026-02-13 查看
510(k) K253516 Assert-IQ (DM5100)MXD2025-12-18 查看
510(k) K252417 Amplatzer Piccolo®輸送系統（9-PDS-04F-045）DQY2025-12-17 查看
510(k) K253232 Seguin Annuloplasty RingKRH2025-10-29 查看
510(k) K250031 Amplatzer導引絲DQX2025-10-03 查看
510(k) K252013 EnSite™ X EP SystemDQK2025-09-25 查看
510(k) K251463 EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)DQK2025-09-04 查看
510(k) K251234 EnSite™ X EP SystemDQK2025-07-30 查看
510(k) K250552 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX2025-07-25 查看
510(k) K242841 Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI2025-05-27 查看
510(k) K251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJ2025-05-23 查看
510(k) K251231 ViewFlex™ X ICE Catheter, Sensor Enabled™OBJ2025-05-20 查看
510(k) K250426 Amulet™ 可導向運送鞘DQY2025-04-25 查看
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