| K252384 — DESS® Dental Smart Solutions | Terrats Medical SL Oct 23, 2025 |
| K250288 — TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. Oct 23, 2025 |
| K253226 — UV5000W Handle | Uroviu Corporation Oct 23, 2025 |
| K252931 — Invisalign® Palatal Expander System | Align Technology, Inc. Oct 23, 2025 |
| K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene Oct 22, 2025 |
| K252322 — SIros-X System | Genesys Spine Oct 22, 2025 |
| K252298 — ANDI 2.0 | Imeka Solutions, Inc. Oct 22, 2025 |
| K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. Oct 22, 2025 |
| K253145 — Pre-Sutured Tendon | Rti Surgical, Inc. Oct 22, 2025 |
| K252325 — Hair Growth Laser Cap | Cosmo Far East Technology Limited Oct 22, 2025 |
| K251977 — electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. Oct 22, 2025 |
| K251628 — Mandibular Advancement Device L07 | Dcstar, Inc. Oct 22, 2025 |
| K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. Oct 22, 2025 |
| K250666 — Alegria Flash CTD Screen | Zeus Scientific Oct 22, 2025 |
| K253144 — Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. Oct 22, 2025 |
| K251030 — Sirona Advanced Imaging Suite | Sirona Medical Oct 22, 2025 |
| K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Oct 22, 2025 |
| K250955 — XC11 ICE System, USA | Yorlabs, Inc. Oct 22, 2025 |
| K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. Oct 22, 2025 |
| K252569 — Carrier XL Delivery Catheter | Balt USA, LLC Oct 22, 2025 |
| K251289 — WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. Oct 22, 2025 |
| K250394 — Fine TTO | Bodycad Laboratories, Inc. Oct 21, 2025 |
| K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. Oct 21, 2025 |
| K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical Oct 21, 2025 |
| K253249 — TriALTIS Spine System | Medos International SARL Oct 21, 2025 |
| K251838 — Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. Oct 21, 2025 |
| K253034 — HemoSphere Stream Module | Edwards Lifesciences Oct 21, 2025 |
| K231897 — NeuroAlign software | Medivis, Inc. Oct 21, 2025 |
| K253040 — Aevumed FASE Suture Anchor | Aevumed, Inc. Oct 21, 2025 |
| K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation Oct 21, 2025 |
| K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. Oct 21, 2025 |
| K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut Für Physik Und Medizin GmbH Oct 21, 2025 |
| K252640 — VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC Oct 20, 2025 |
| K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. Oct 20, 2025 |
| K252665 — brAIn Shoulder Positioning | Avatar Medical Oct 20, 2025 |
| K252155 — AVAVA Skin Treatment System | AVAVA, Inc. Oct 20, 2025 |
| K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited Oct 20, 2025 |
| K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. Oct 20, 2025 |
| K242827 — A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. Oct 20, 2025 |
| K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. Oct 20, 2025 |
| K252254 — Osteotomy Wedge System | Sinaptic Surgical Oct 17, 2025 |
| K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH Oct 17, 2025 |
| K250911 — MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. Oct 17, 2025 |
| K250178 — Adin Customized Abutments | Adin Dental Implant Systems , Ltd. Oct 17, 2025 |
| K251778 — Remi Custom Night Guard | Remi Oct 17, 2025 |
| K250203 — SureAx-Guide | Sureax Medical, LLC Oct 17, 2025 |
| K250145 — Biopsy Port Adapter | Endosound, Inc. Oct 17, 2025 |
| K251832 — InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular Oct 17, 2025 |
| K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. Oct 17, 2025 |
| K250197 — Estremo Fibular Nail | Citieffe S.R.L. Oct 17, 2025 |