510(k) Clearances — Page 131
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240801 — BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240477 — Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240353 — Hyper Insight - ICH | Sk, Inc. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240536 — Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240070 — Profound Matrix | Candela Corporation Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240221 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | Covidien, LLC Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241639 — Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. Mon Jul 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241608 — nordicMEDiVA | Nordicneurolab AS Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232865 — Magseed Pro Magnetic Marker System | Endomagnetics Ltd., Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241229 — Hello,eyes® BIO Plug | Bio Optics Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233823 — Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241204 — TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241154 — Electric Wheelchair (YFWB-63) | If Health (Xiamen) Intelligent Technology Co.,Ltd Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240892 — XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240215 — BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240927 — Access Thyroglobulin | Beckman Coulter, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241406 — Lavieen | Wontech Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240164 — NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240320 — Patient Monitor (RespArray) | Edan Instruments, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233637 — Cordis BRITECROSS Support Catheter | Cordis US Corp Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240893 — ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240938 — The Optimotion Blue Plus Knee System | Optimotion Implants, LLC Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | Sleepnet Corporation Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241542 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240853 — Pathfinder® CR System | Neptune Medical, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241506 — Annabella Double Breast Pump (ADO-US23-1000) | Annabella Tech Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230055 — FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | Balance Ophthalmics, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241212 — MagnetOs Easypack Putty | Kuros Biosciences Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233762 — SteroScope® Sterilization Technology System | Ideate Medical, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233357 — EsoCool Thermal Regulation Catheter | Nuvaira, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240381 — CATALYSTEM Femoral Stems | Smith & Nephew, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240327 — UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241509 — TENS&EMS units (SM9109A, SM9109B) | Plexus Yoga, LLC Dba Chirp Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240823 — els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | Edwards Lifesciences Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240564 — NuFACE® FIX+ | Carol Cole Company Dba Nuface® Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240016 — Xpert HCV; GeneXpert Xpress System | Cepheid Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233398 — Faros Surgical System | Oertli Instrumente AG Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233579 — SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233380 — TRIDENT Mobile Fluoroscopy System | Dornier Medtech America Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232987 — FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232829 — Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222771 — Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233840 — Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) | Zhuhai Dipu Medical Technology Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |