510(k) Clearances — Page 149
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240530 — DynaNail Mini Tapered Hybrid | MedShape, Inc. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234081 — RedDrop ONE (One) | Reddrop DX Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | DePuy Synthes Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240179 — Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240754 — N2 | Megagen Implant Co., Ltd. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230088 — Ankle Truss System (ATS) | 4Web Medical, Inc. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232439 — Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234062 — APTUS Hand Scaphoid Plates | Medartis AG Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233753 — AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233926 — accufit | Mettler Electronics Corporation Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Ipg Medical Corporation Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240743 — Peak Universal Bond | Ultradent Products, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240574 — BruxZir® Radiant | Prismatik Dentalcraft, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233642 — InMode RF System | InMode , Ltd. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233002 — BEED 2,5, BEED 3,8 | Excelsior Resources, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232654 — Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233375 — Tranquil-L Interbody System | Nexus Spine, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240537 — SMARTXIDE PRO | El.En S.P.A. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231974 — PATHFAST®hs-cTnI-II | Phc Corporation Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240507 — NuVasive AttraX Scaffold | Nuvasive, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234047 — Automatic Registration | Brainlab AG Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234049 — Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234052 — Access Ferritin | Beckman Coulter, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232125 — V-PVP | Vitromed GmbH Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233772 — Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232619 — MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233146 — Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234024 — HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231719 — Medical Surgical Mask | Azur Medical Company, Inc. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232682 — Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240668 — Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231843 — ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240113 — CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233599 — X-Clever (ASHK100G) | Lg Electronics.Inc Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240515 — uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240139 — Real Intelligence CORI | Blue Belt Technologies, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233660 — nCommand Lite System | Ionic Health Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230981 — Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. Sat Mar 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240117 — Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234115 — APRO 55 Catheter | Alembic, LLC Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240112 — Light Cure Composite | Sincera Technology (Changchun) Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232327 — Endorail | Endostart S.R.L. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230802 — Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233814 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240694 — FORMA Composite (Shade A3D) | Ultradent Products, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |