510(k) Clearances — Page 128
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233768 — Papacarie Duo | Elevate Oral Care Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241206 — Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240340 — Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241321 — Juliet® Ti LL Lumbar Interbody Device | Spineart SA Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241463 — Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | Suzhou Master Machinery Manufacturing Co.,Ltd Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212521 — Field Shield Wound Dressing | Kericure, Inc. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241879 — vRad Viewer | Virtual Radiologic Corporation Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221495 — SOLID CLIP Single Use Clip Applier | Medscope Biotech Co., Ltd. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233482 — Equinoxe® Central Screw Baseplate System | Exactech, Inc. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240503 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240609 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240845 — Rayvolve | Azmed Sas Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241467 — Stable-C Interbody System | Nexus Spine, LLC Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241121 — MICSI-RMT | Microstructure Imaging, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241413 — sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240705 — Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241050 — CrossRoads Modular Tray System | Crossroads Extremity Systems Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241441 — RadiForce RX670; RadiForce RX670-AR | Eizo Corporation Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241741 — SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230061 — allay Nerve Cap | Tulavi Therapeutics Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240272 — Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241056 — Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241740 — Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240944 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | Diasorin Molecular, LLC Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241739 — Endoscopic Applicator, 41 cm | Micromedics, Inc. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240616 — FAQ (102) | Foreo, Inc. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233458 — CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical , Ltd. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241032 — BellaTek Bars | Biomet 3i, LLC Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233460 — CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240178 — RFG-01 | Zimmer Medizinsysteme GmbH Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233449 — Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241385 — Omnifix Syringe NRFit | B.Braun Medical, Inc. Sat Jul 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241705 — MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) | Milkmate Products, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240247 — MoFi Cell Culture Basal Medium | Duogenic Stemcells Corporation Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240661 — Geistlich Bio-Oss® | Geistlich Pharma AG Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241018 — KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241031 — TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240651 — MRI Universal | Stryker Leibinger GmbH & Co KG Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233457 — RUS | Hutom, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Megadyne Medical Products, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |