510(k) Clearances — Page 107
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241814 — da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243506 — Montage-XT Settable Bone Putty | Orthocon, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242092 — MICRO Arterial Filters | Sorin 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) |
| 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) |
| K240871 — Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242062 — 1CMR Pro | Mycardium AI Limited Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242800 — The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243285 — TMINI Miniature Robotic System | THINK Surgical, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242960 — AdVance XP Male Sling System (720163-03) | Boston Scientific Corporation Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240528 — b-ONE® Total Hip System | B-One Ortho, Corp. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233081 — NUVENTUS NV.C Dental Implant System | Infinitum Eta, Ltd. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242130 — Koios DS | Koios Medical, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241138 — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator | Livsmed, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241439 — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243299 — ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241125 — VIVIX-S 1751S | Vieworks Co., Ltd. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241070 — Gelsoft Plus Vascular Prostheses | Vascutek, Ltd. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240860 — EchoGo Amyloidosis (1.0) | Ultromics Limited Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242079 — Arthrex Elbow Fracture Plating System | Arthrex, Inc. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242814 — Tandry Q-Locking Plate System | Microware Precision Co., Ltd. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242436 — Proximal Humerus Fixation System | Skeletal Dynamics, Inc. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242598 — DEFINE System (AG612444A) | InMode , Ltd. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242940 — Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242440 — Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241930 — Veincare | Wontech Co., Ltd. Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242342 — Fetal EchoScan | Brightheart Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241339 — Besmed Bacterial Filter and HMEF | Besmed Health Business Corp Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241397 — Hinscope | Hinlab Sas Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | Huizhou Foryou Medical Devices Co., Ltd. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211498 — Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242407 — Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243273 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241135 — RESPOND(R) Ventilator | Corvent Medical, Inc. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242764 — MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240023 — SmartFlow Neuro Cannula | ClearPoint Neuro, Inc. Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242791 — Electric wheelchair (KR-8807) | Zhejiang Kairui Medical Device Co., Ltd. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230085 — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Steris Tue Nov 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |