| K250739 — Primeprint Direct Aligner | Dreve Dentamid GmbH Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252041 — Fibresolve (with PCCP) | Imvaria, Inc. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252519 — CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243131 — Triathlon Pro | Sigma Biomedical Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251391 — BrainsWay Deep TMS System | Brainsway , Ltd. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250264 — SugarBug (1.x) | Bench7, Inc. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252515 — Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250815 — Hubly Drill (H100) | Hubly, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250423 — mb-FIX Cranial Stabilization Systems | Medical Bees GmbH Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253074 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253265 — BriefCase-Triage | Aidoc Medical , Ltd. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251555 — Ultra Compression Screw System | Pace Surgical Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252418 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252845 — Venus Nova (FP-2001) | Venus Concept, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252133 — Adaptix Ortho350 | Adaptix Limited Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252525 — AIO Breathe | Aiomega, LLC Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250375 — Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250376 — ViVY | Viatherm Therapeutics, LLC Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252514 — EVAC-MRI | Phasor Health, LLC Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252677 — Polyshield Safety IV Catheters | Poly Medicure Limited Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250599 — ExcelsiusGPS Instruments | Globus Medical, Inc. Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252664 — GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251303 — Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251709 — MedCAD® AccuStride System | Medcad Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251410 — VXvue | Vieworks Co., Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250853 — Merit Syringe | Merit Medical Systems, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252964 — PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250576 — Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250241 — Cios Select | Siemens Medical Solutions USA, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250330 — 3mensio Workstation | Pie Medical Imaging BV Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251626 — Midmark Dental Delivery System | Midmark Corporation Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252484 — cobas HCV | Roche Molecular Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253448 — Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252458 — Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252671 — Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252481 — cobas CMV | Roche Molecular Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252698 — NightGuard Aire Max | Nightguard Express, LLC Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250392 — ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240074 — Pulsenmore ES | Pulsenmore, Ltd. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |