510(k) Clearances

174,759 clearances total

K243405 — Xpert vanACepheid® Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242799 — PliaFX FloLifenet Health Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242871 — ATTUNE™ Revision Hinge KneeDepuy Ireland UC Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241157 — Secret MAX Multi-platform RF SystemIlooda Co,., Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242414 — TiLink-P Joint Fusion SystemSurGenTec, LLC Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242553 — MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241210 — Luja CoudeColoplast Corp. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240716 — AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242517 — ProAM ACDF SystemPro Surgical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242521 — Estar-ZEOsstem Implant Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241843 — TD-7301 Spirometer (TD-7301)Gostar Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243164 — INDIBA COMPACT devicesIndiba S. A. U. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242359 — Strain AI (SAI001)Exo, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242520 — Element Vascular Access SystemPenumbra, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240746 — Neurovascular Access System FamilyQ'Apel Medical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242363 — HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241603 — Powered Wheelchair (NXN20-208, NXN20-211)Zhejiang Nysin Medical Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232965 — Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242293 — Medical Thulium Fiber Laser Systems (UroFiber 60Q)Rhein Laser Technologies Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242102 — CerroZone MiniCerrozone, LLC Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243323 — Iconix Knotless AnchorRiverpoint Medical Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243277 — Freedom® Medial Congruent LinerMaxx Orthopedics, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242523 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242516 — EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)Braxx Biotech Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243316 — XENOVIEW 3.0T Chest CoilPolarean, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)Dongguanshi Yiyingmei Technology Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221813 — Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242930 — Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241747 — Saige-DxDeepHealth, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242329 — CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243506 — Montage-XT Settable Bone PuttyOrthocon, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242092 — MICRO Arterial FiltersSorin Group Italia S.R.L. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241498 — Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241633 — Informed Vital Core Application (IVC App)Mindset Medical, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242471 — Power Wheelchair (W5538)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241700 — Tenex 2nd Generation SystemTrice Medical, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243320 — Air Pressure Therapy System (VU-IPC04B)Xiamen Weiyou Intelligent Technology Co., Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242402 — Power wheelchairZhejiang Zhonglei Medical Technology Co. , Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241814 — da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240871 — Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242800 — The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242062 — 1CMR ProMycardium AI Limited Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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