510(k) Clearances — Page 53
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251931 — BioTraceIO Vision (V1.7) | Techsomed Medical Technologies Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251892 — MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250928 — OmniTom Elite with PCD | Neurologica Corporation Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251957 — Coaptium Connect with Tissium Light | Tissium SA Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251610 — qER-CTA (v1.0) | Qure.Ai Technologies Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250229 — Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251394 — Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251754 — Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251227 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250960 — DUO Microcatheter | Rev Neuro, LLC Mon Sep 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250460 — WatchPAT400 (WP400) | Itamar Medical , Ltd. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250132 — Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250095 — All-Suture Dual Anchor System | Suturetech, Inc. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244038 — High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251317 — SOLOPASS 2.0 System | Intravent Medical Partners Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252528 — Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251250 — ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243795 — pREBOA-PRO Catheter | Prytime Medical Devices, Inc. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251753 — GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251022 — 3D-SHAPER | 3D-Shaper Medical S.L Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243700 — Apollo TMS Therapy System | Mag & More GmbH Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250353 — Oniris; Oniris Plus | Oniris Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251533 — Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251168 — Image Suite | Carestream Health, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250893 — Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251733 — Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251737 — NextAR(TM) Shoulder Platform | Medacta International S.A. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251463 — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | ABBOTT MEDICAL Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251444 — Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251545 — Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251656 — Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. , Ltd. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251510 — Symani Surgical System | Medical Microinstruments, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251298 — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems, AB Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250770 — Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250064 — Dose+ (1.0) | Mvision AI OY Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251781 — KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251457 — Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231952 — MEDILIGHT | Medicreations, LLC Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250217 — AGNES Ultra | Agnes Medical Co., Ltd. Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252174 — AquaCast Mask | Blessing Cathay Corporation Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252454 — Kinos Total Ankle System | Restor3D Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251909 — NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250765 — AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252446 — BruxZir® NOW | Prismatik Dentalcraft, Inc. Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |