| K251317 — SOLOPASS 2.0 System | Intravent Medical Partners Sep 5, 2025 |
| K251753 — GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. Sep 5, 2025 |
| 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. Sep 5, 2025 |
| K252528 — Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. Sep 5, 2025 |
| 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 Sep 5, 2025 |
| K251250 — ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 5, 2025 |
| K243795 — pREBOA-PRO Catheter | Prytime Medical Devices, Inc. Sep 5, 2025 |
| K251022 — 3D-SHAPER | 3D-Shaper Medical S.L Sep 5, 2025 |
| K251168 — Image Suite | Carestream Health, Inc. Sep 4, 2025 |
| K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. Sep 4, 2025 |
| K243700 — Apollo TMS Therapy System | Mag & More GmbH Sep 4, 2025 |
| K250353 — Oniris; Oniris Plus | Oniris Sep 4, 2025 |
| K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. Sep 4, 2025 |
| K251545 — Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. Sep 4, 2025 |
| K250893 — Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. Sep 4, 2025 |
| K251533 — Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. Sep 4, 2025 |
| K251733 — Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) Sep 4, 2025 |
| K251737 — NextAR(TM) Shoulder Platform | Medacta International S.A. Sep 4, 2025 |
| 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 Sep 4, 2025 |
| K251444 — Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. Sep 4, 2025 |
| K251656 — Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. , Ltd. Sep 4, 2025 |
| K251510 — Symani Surgical System | Medical Microinstruments, Inc. Sep 4, 2025 |
| 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 Sep 4, 2025 |
| K250770 — Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. Sep 4, 2025 |
| K250064 — Dose+ (1.0) | Mvision AI OY Sep 4, 2025 |
| K251781 — KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Sep 4, 2025 |
| K251457 — Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. Sep 3, 2025 |
| K250217 — AGNES Ultra | Agnes Medical Co., Ltd. Sep 3, 2025 |
| K231952 — MEDILIGHT | Medicreations, LLC Sep 3, 2025 |
| K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine Sep 3, 2025 |
| K251909 — NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering Sep 3, 2025 |
| K252454 — Kinos Total Ankle System | Restor3D Sep 3, 2025 |
| K252174 — AquaCast Mask | Blessing Cathay Corporation Sep 3, 2025 |
| K250765 — AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation Sep 3, 2025 |
| K252446 — BruxZir® NOW | Prismatik Dentalcraft, Inc. Sep 3, 2025 |
| K252539 — Tempus Pixel | Arterys, Inc. Sep 3, 2025 |
| K251726 — SignalNED System (Model RE) | Forest Devices, Inc. Sep 3, 2025 |
| K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. Sep 3, 2025 |
| K251615 — Aerogen Pro-X1 Controller System | Aerogen, Ltd. Sep 2, 2025 |
| K251775 — RODIN Cement | Belport Company, Inc., Gingi-Pak Sep 2, 2025 |
| K242768 — Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. Sep 2, 2025 |
| K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH Sep 2, 2025 |
| K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion Sep 2, 2025 |
| K251408 — OsteoSight Hip (v1) | Naitive Technologies, Ltd. Sep 2, 2025 |
| K250753 — VELMENI for DENTISTS (V4D) | Velmeni, Inc. Sep 2, 2025 |
| K252364 — Edwards eSheath Optima introducer set | Edwards Lifesciences Aug 29, 2025 |
| K251106 — Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. Aug 29, 2025 |
| K251217 — SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. Aug 29, 2025 |
| K251026 — Regenesis EMS Chair | Trinity Medical Solutions Aug 29, 2025 |
| K250335 — IVA & AEON Cervical and Lumbar Cage System | K&J Consulting Aug 29, 2025 |