510(k) Clearances — Page 78
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243861 — butterflyBVM | Compact Medical, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250554 — prodisc® L Instruments | Centinel Spine, LLC Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250892 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242469 — RFMagik Lite | Agnes Medical Co., Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250153 — Neu Platform | Neuhealth Digital , Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243954 — PeriCross Epicardial Access Kit | Circa Scientific, Inc. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250002 — Smart Check O2 (MA0236) | Life Spark Medical, LLC Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250206 — Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242214 — Sonu | Sound Health Systems, Inc. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250183 — CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243239 — Lung AI (LAI001) | Exo, Inc. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250262 — GO-PEN® | Go-Pen Aps Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233337 — Freespira Breathing System | Freespira, Inc. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242973 — CanMINI Hand and Foot System | Canwell Medical Co., Ltd. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250116 — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243714 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250198 — Laon Ortho | Laon Medi, Inc. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243326 — Dynamis Robotic Surgical System | LEM Surgical AG Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243697 — MySpine WebPlanner | Medacta International S.A. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250831 — Annalise Enterprise | Annalise-Ai Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250944 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | Gmp Medicare Sdn. Bhd. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250155 — Xpert Knee | Newclip Technics Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242232 — Mpact 3D Metal Augments II | Medacta International S.A. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250228 — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) | Esonic Technology (Wuhan) Co., Ltd. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243479 — EchoGuide (Version 1) | Sonavex, Inc. Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250869 — Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243621 — Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242247 — ARIX Femur Nail System | Jeil Medical Corporation Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242542 — Medentika CAD/CAM Abutments | Medentika GmbH Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243343 — BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243386 — Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241931 — OcuMet Beacon (OCUB100) | Ocusciences, Inc. Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243944 — Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251196 — Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243651 — VersaViewer | GE Medical Systems SCS Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243383 — CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250176 — DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243875 — Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243508 — Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. Mon Apr 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242170 — K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243734 — Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |