| 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 |
| K252427 — Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. Oct 31, 2025 |
| K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation Oct 31, 2025 |
| K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. Oct 31, 2025 |
| K250338 — MSS - Humeral reverse liners extension | Medacta International S.A. Oct 31, 2025 |
| K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda Oct 31, 2025 |
| K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson And Company Oct 31, 2025 |
| DEN240074 — Pulsenmore ES | Pulsenmore, Ltd. Oct 31, 2025 |
| K252060 — GREEN | Phasor Health, LLC Oct 31, 2025 |
| K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC Oct 31, 2025 |
| K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Oct 31, 2025 |
| K252088 — Firebird SI Navigation System | Orthofix US, LLC Oct 31, 2025 |
| K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. Oct 31, 2025 |
| K252442 — Kii Structural Balloon Access System | Applied Medical Resources Corp. Oct 31, 2025 |
| K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. Oct 31, 2025 |
| K250306 — Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. Oct 31, 2025 |
| K252046 — Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. Oct 30, 2025 |
| K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. Oct 30, 2025 |
| K251938 — GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC Oct 30, 2025 |
| K250337 — AiORTA - Plan | ViTAA Medical Solutions, Inc. Oct 30, 2025 |
| K250325 — BD Alaris Pump Infusion Set | Carefusion (Bd) Oct 30, 2025 |
| K251531 — AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC Oct 30, 2025 |
| K252752 — ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. Oct 30, 2025 |