510(k) Clearances — Page 127
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K220328 — EasyStat 300 | Medica Corporation Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233563 — Navident | Claronav, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | Cosmo Artificial Intelligence - Ai, Ltd. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241864 — Grappler Interference Screw System | Paragon 28, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | Stryker Leibinger GmbH & Co KG Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241361 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241063 — s-Clean ScanHealing Abutment | Dentis Co., Ltd. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233372 — KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241203 — PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) | Dongguan Hunter Electronic Technology Co., Ltd. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233352 — Aptima HCV Quant Dx Assay | Hologic, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241789 — Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241130 — POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240780 — InMode RF System | InMode , Ltd. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230305 — THE Graft Collagen | Purgo Biologics, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241150 — MISTI Silicone Implant | Keosan Trading Co. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | Centerline Biomedical, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240714 — Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231251 — FlexWing Anterior Cervical Plate System | Jeil Medical Corporation Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241502 — P-SCOPE | Oui Medical, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240044 — CADDIE | Odin Medical Limited Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233865 — X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240756 — AITRICS-VC | Aitrics Co., Ltd. Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240906 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241296 — Gaudi Proximal Humerus Plate | Netbiologics, LLC Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240339 — Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) | Shanghai Bangbang Robotics Co., Ltd. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240558 — NAVOYCDS | Algodx AB Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241119 — Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241445 — K-Bond Universal | Spident Co., Ltd. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231133 — neo315 | Neoscan Solution GmbH Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241116 — Onycho Laser V | Terasysd&C, Inc. Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241482 — Kinos Total Ankle System | Restor3D Mon Jul 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240347 — PTG-05 | Zimmer Medizinsysteme GmbH Sun Jul 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233979 — VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240538 — Premium Teeth Resin | Formlabs Ohio, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233866 — Senhance Surgical System | Asensus Surgical, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241809 — coactiv+ Antimicrobial Wound Gel | Kane Biotech, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233976 — VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science and Technology Co., Ltd. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240835 — Suture Button Repair System | Skeletal Dynamics, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233917 — ICHOR 7F Embolectomy System (ICH-7F) | Ichor Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |