510(k) Clearances — Page 122

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 122 of 3,525)
ClearancesDetails
K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)Dongguanshi Yiyingmei Technology Co., Ltd. Nov 19, 2024
K242293 — Medical Thulium Fiber Laser Systems (UroFiber 60Q)Rhein Laser Technologies Co., Ltd. Nov 19, 2024
K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation Nov 19, 2024
K243277 — Freedom® Medial Congruent LinerMaxx Orthopedics, Inc. Nov 19, 2024
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. Nov 19, 2024
K242516 — EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC Nov 19, 2024
K242102 — CerroZone MiniCerrozone, LLC Nov 19, 2024
K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)Braxx Biotech Co., Ltd. Nov 19, 2024
K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited Nov 19, 2024
K243316 — XENOVIEW 3.0T Chest CoilPolarean, Inc. Nov 19, 2024
K221813 — Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation Nov 19, 2024
K242930 — Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Nov 19, 2024
K242471 — Power Wheelchair (W5538)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Nov 18, 2024
K241747 — Saige-DxDeepHealth, Inc. Nov 18, 2024
K241700 — Tenex 2nd Generation SystemTrice Medical, Inc. Nov 18, 2024
K242329 — CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd. Nov 18, 2024
K241814 — da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc. Nov 18, 2024
K242402 — Power wheelchairZhejiang Zhonglei Medical Technology Co. , Ltd. Nov 18, 2024
K243506 — Montage-XT Settable Bone PuttyOrthocon, Inc. Nov 18, 2024
K242092 — MICRO Arterial FiltersSorin Group Italia S.R.L. Nov 18, 2024
K241498 — Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd Nov 18, 2024
K241633 — Informed Vital Core Application (IVC App)Mindset Medical, Inc. Nov 18, 2024
K243320 — Air Pressure Therapy System (VU-IPC04B)Xiamen Weiyou Intelligent Technology Co., Ltd. Nov 18, 2024
K240871 — Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. Nov 18, 2024
K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)Surgical Instrument Service And Savings Inc.(Dba Medline Ren Nov 15, 2024
K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorDent4You AG Nov 15, 2024
K242062 — 1CMR ProMycardium AI Limited Nov 15, 2024
K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc. Nov 15, 2024
K240528 — b-ONE® Total Hip SystemB-One Ortho, Corp. Nov 15, 2024
K233081 — NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd. Nov 15, 2024
K242960 — AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation Nov 15, 2024
K242130 — Koios DSKoios Medical, Inc. Nov 15, 2024
K243285 — TMINI Miniature Robotic SystemTHINK Surgical, Inc. Nov 15, 2024
K241138 — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal GeneratorLivsmed, Inc. Nov 15, 2024
K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc. Nov 15, 2024
K241439 — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. Nov 15, 2024
K242800 — The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC Nov 15, 2024
K243299 — ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Nov 15, 2024
K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd. Nov 15, 2024
K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. Nov 15, 2024
K241125 — VIVIX-S 1751SVieworks Co., Ltd. Nov 15, 2024
K241070 — Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. Nov 15, 2024
K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech Co., Ltd. Nov 15, 2024
K242272 — CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. Nov 15, 2024
K240860 — EchoGo Amyloidosis (1.0)Ultromics Limited Nov 15, 2024
K242940 — Xrecovery (XR-001)Shenzhen Xinrun Electric Appliances Co, Ltd. Nov 14, 2024
K242079 — Arthrex Elbow Fracture Plating SystemArthrex, Inc. Nov 14, 2024
K242598 — DEFINE System (AG612444A)InMode , Ltd. Nov 14, 2024
K241930 — VeincareWontech Co., Ltd. Nov 14, 2024
K242814 — Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd. Nov 14, 2024
← Previous Page 122 of 3525 Next →