| K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 7, 2025 |
| K252041 — Fibresolve (with PCCP) | Imvaria, Inc. Nov 7, 2025 |
| K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company Nov 7, 2025 |
| K252519 — CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd Nov 7, 2025 |
| K243131 — Triathlon Pro | Sigma Biomedical Nov 7, 2025 |
| K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda Nov 7, 2025 |
| K251391 — BrainsWay Deep TMS System | Brainsway , Ltd. Nov 7, 2025 |
| K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation Nov 7, 2025 |
| K250264 — SugarBug (1.x) | Bench7, Inc. Nov 7, 2025 |
| K250815 — Hubly Drill (H100) | Hubly, Inc. Nov 6, 2025 |
| K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. Nov 6, 2025 |
| K252418 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Nov 6, 2025 |
| K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. Nov 6, 2025 |
| K252525 — AIO Breathe | Aiomega, LLC Nov 6, 2025 |
| K250423 — mb-FIX Cranial Stabilization Systems | Medical Bees GmbH Nov 6, 2025 |
| K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. Nov 6, 2025 |
| K253074 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Nov 6, 2025 |
| K252515 — Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd Nov 6, 2025 |
| K251555 — Ultra Compression Screw System | Pace Surgical Nov 6, 2025 |
| K253265 — BriefCase-Triage | Aidoc Medical , Ltd. Nov 6, 2025 |
| K252845 — Venus Nova (FP-2001) | Venus Concept, Inc. Nov 6, 2025 |
| K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. Nov 6, 2025 |
| K252133 — Adaptix Ortho350 | Adaptix Limited Nov 6, 2025 |
| K250375 — Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG Nov 5, 2025 |
| K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. Nov 5, 2025 |
| K252514 — EVAC-MRI | Phasor Health, LLC Nov 5, 2025 |
| K250376 — ViVY | Viatherm Therapeutics, LLC Nov 5, 2025 |
| K252677 — Polyshield Safety IV Catheters | Poly Medicure Limited Nov 5, 2025 |
| K250599 — ExcelsiusGPS Instruments | Globus Medical, Inc. Nov 5, 2025 |
| K252664 — GMReis Suture Anchors | GM Dos Reis Industria E Comercio Ltda. Nov 4, 2025 |
| K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. Nov 4, 2025 |
| K251410 — VXvue | Vieworks Co., Ltd. Nov 4, 2025 |
| K251303 — Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. Nov 4, 2025 |
| K251709 — MedCAD® AccuStride System | Medcad Nov 4, 2025 |
| K250853 — Merit Syringe | Merit Medical Systems, Inc. Nov 4, 2025 |
| K252964 — PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. Nov 4, 2025 |
| K250576 — Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. Nov 4, 2025 |
| K250241 — Cios Select | Siemens Medical Solutions USA, Inc. Nov 4, 2025 |
| K253448 — Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. Nov 3, 2025 |
| K251626 — Midmark Dental Delivery System | Midmark Corporation Nov 3, 2025 |
| K252484 — cobas HCV | Roche Molecular Systems, Inc. Nov 3, 2025 |
| K252458 — Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. Nov 3, 2025 |
| K250330 — 3mensio Workstation | Pie Medical Imaging BV Nov 3, 2025 |
| K252671 — Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. Nov 3, 2025 |
| K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Nov 3, 2025 |
| K252481 — cobas CMV | Roche Molecular Systems, Inc. Nov 3, 2025 |
| K252698 — NightGuard Aire Max | Nightguard Express, LLC Nov 3, 2025 |
| K250392 — ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. Nov 3, 2025 |
| K251547 — DESS Dental Smart Solutions | Terrats Medical SL Oct 31, 2025 |
| K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. Oct 31, 2025 |