| Invisalign® Palatal Expander System (K252931) | Align Technology, Inc. | 2025-10-23 |
| Picosecond Laser Device (PF131-BI) (K252345) | Risu Medical Technology Co., Ltd. | 2025-10-23 |
| PerQseal Introducers (K252309) | Vivasure Medical Limited | 2025-10-23 |
| TeraRecon Cardiovascular.Calcification.CT (K250288) | Terarecon,Inc. | 2025-10-23 |
| 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 (K253147) | Prosidyan, Inc. | 2025-10-22 |
| Mandibular Advancement Device L07 (K251628) | Dcstar, Inc. | 2025-10-22 |
| Freedom® Total Knee System – Titan PCK Components (K253144) | Maxx Orthopedics, Inc. | 2025-10-22 |
| electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) (K251977) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-10-22 |
| Carrier XL Delivery Catheter (K252569) | Balt USA, LLC | 2025-10-22 |
| ANDI 2.0 (K252298) | Imeka Solutions, Inc. | 2025-10-22 |
| Sirona Advanced Imaging Suite (K251030) | Sirona Medical | 2025-10-22 |
| XC11 ICE System, USA (K250955) | Yorlabs, Inc. | 2025-10-22 |
| Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663) | Datex-Ohmeda, Inc. | 2025-10-22 |
| Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) | ACON Laboratories, Inc. | 2025-10-22 |
| SIros-X System (K252322) | Genesys Spine | 2025-10-22 |
| Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (K251185) | Intervene | 2025-10-22 |
| Alegria Flash CTD Screen (K250666) | Zeus Scientific | 2025-10-22 |
| Pre-Sutured Tendon (K253145) | Rti Surgical, Inc. | 2025-10-22 |
| Hair Growth Laser Cap (K252325) | Cosmo Far East Technology Limited | 2025-10-22 |
| WELLlife COVID-19 Antigen Test Rx (K251289) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329) | QIAGEN GmbH | 2025-10-22 |
| Aevumed FASE Suture Anchor (K253040) | Aevumed, Inc. | 2025-10-21 |
| ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (K250126) | Livsmed, Inc. | 2025-10-21 |
| Fine TTO™ (K250394) | Bodycad Laboratories, Inc. | 2025-10-21 |
| Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (K253033) | Simplivia Healthcare , Ltd. | 2025-10-21 |
| Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (K250409) | Olympus Medical Systems Corporation | 2025-10-21 |
| NeuroAlign software (K231897) | Medivis, Inc. | 2025-10-21 |
| HemoSphere Stream Module (K253034) | Edwards Lifesciences | 2025-10-21 |
| TriALTIS™ Spine System (K253249) | Medos International SARL | 2025-10-21 |
| Neuromuscular Transmission Monitor TOF3D (2510091) (K250887) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025-10-21 |
| OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252346) | Astura Medical | 2025-10-21 |
| Introducer Sheath Set (K251838) | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 |
| brAIn™ Shoulder Positioning (K252665) | Avatar Medical | 2025-10-20 |
| A8 INTEGR8™ Porous Pedicle Screws (K242827) | Allumin8, Inc. | 2025-10-20 |
| AVAVA™ Skin Treatment System (K252155) | AVAVA, Inc. | 2025-10-20 |
| InkSpace Imaging Small Body Array (SBA12PH30x) (K253182) | Inkspace Imaging, Inc. | 2025-10-20 |
| Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (K251414) | Feeltech Co., Ltd. | 2025-10-20 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| Q-Switched Nd: YAG Laser machine (LFS-C13U) (K252319) | Sanhe Lefis Electronics Co., Ltd. | 2025-10-20 |
| VereSee Optical Veres Needle and Endoscopic Camera (K252640) | Freyja Healthcare, LLC | 2025-10-20 |
| Estremo Fibular Nail (K250197) | Citieffe S.R.L. | 2025-10-17 |
| MOSkin Radiation Measurement System (K250911) | Electrogenics Labs, Ltd. | 2025-10-17 |
| S.I.N. Dental Implant System (K252266) | S.I.N. Implant System Ltda | 2025-10-17 |
| ADVIA Centaur Anti-Thyroid Peroxidase II (K250250) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Osteotomy Wedge System (K252254) | Sinaptic Surgical | 2025-10-17 |
| Remi Custom Night Guard (K251778) | Remi | 2025-10-17 |
| MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) (K252264) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | 2025-10-17 |
| InZone IST Detachment System; IZDS Connecting Cable (K251832) | Stryker Neurovascular | 2025-10-17 |
| Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159) | The Binding Site Group , Ltd. | 2025-10-17 |
| JOVS Electric Stimulation Beauty Device (JE2) (K250227) | Shenzhen Qianyu Technology Co., Ltd. | 2025-10-17 |
| X9 Ultrasound System (K251673) | X9, Inc. | 2025-10-17 |
| Adin Customized Abutments (K250178) | Adin Dental Implant Systems , Ltd. | 2025-10-17 |
| Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (K250945) | Olympus Medical Systems Corp. | 2025-10-17 |
| Modius Lean (DEN240076) | Neurovalens Limited | 2025-10-17 |
| IntelliVue Patient monitors MX400, MX450, MX500, MX550 (K251146) | Philips Medizin Systeme Boeblingen GmbH | 2025-10-17 |
| X1-FFR (K251355) | Spectrawave, Inc. | 2025-10-17 |
| Program insite® Powder-Free, Disposable Nitrile Exam Gloves (K252075) | Program Insite, LLC | 2025-10-17 |
| StealthStation S8 Spine Software (K251282) | Medtronic Navigation, Inc. | 2025-10-17 |
| SureAx-Guide™ (K250203) | Sureax Medical, LLC | 2025-10-17 |
| Biopsy Port Adapter (K250145) | Endosound, Inc. | 2025-10-17 |
| ProZip Knotless Implant (K253024) | Riverpoint Medical | 2025-10-16 |
| INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (K252612) | Penumbra, Inc. | 2025-10-16 |
| Light Therapy Mask (1019055) (K252093) | Merchsource, LLC | 2025-10-16 |
| Alpha Endo Handpiece (Alpha Endo) (K252223) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 |
| NeurAxis IB-Stim (01-1020) (K252024) | Neuraxis | 2025-10-16 |
| FFX Facet Fixation System (K252153) | Sc Medica | 2025-10-16 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476) | Brainlab AG | 2025-10-16 |
| CryoFreeze Wart and Skin Tag Remover (K253000) | Cryosurgery, Inc. | 2025-10-16 |
| TargetCool™ (RM-DT02W) (K253114) | Recensmedical, Inc. | 2025-10-16 |
| Elos Accurate Hybrid Base (K251497) | Elos Medtech Pinol A/S | 2025-10-16 |
| MateLaser Medical Diode Laser Systems (ML-DLS-30) (K250731) | Matelaser, Inc. | 2025-10-16 |
| Profoject™ Disposable Needle (K252631) | CMT Health PTE., Ltd. | 2025-10-16 |
| Re:Balans (K243727) | Mode Sensors AS | 2025-10-16 |
| Arthrex Synergy Vision Imaging System (K251994) | Arthrex, Inc. | 2025-10-16 |
| SurgiAid Collagen Wound Dressing (HA) (K242100) | Maxigen Biotech, Inc. | 2025-10-16 |
| Uterine Aspiration Set (K251882) | Gcmedica Enterprise Ltd.(Wuxi) | 2025-10-16 |
| Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) (K252247) | Olympus Medical Systems Corporation | 2025-10-16 |
| Coolfase (K250852) | Asterasys Co., Ltd. | 2025-10-16 |
| Sure-Fine Insulin Syringes (K250510) | Shina Med Corporation | 2025-10-15 |
| Bonafix Implant Abutments (K251294) | Zentek Medical, LLC | 2025-10-15 |
| BioBrace® Extra-Articular Ligament Augmentation Kit (K252946) | Conmed Corporation | 2025-10-15 |
| TargetCool-e (K253348) | Recensmedical, Inc. | 2025-10-15 |
| AGFA HealthCare Enterprise Imaging (K252199) | Agfa Healthcare N.V. | 2025-10-15 |
| syngo.CT Dual Energy (K251805) | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| InbellaMulti System (K252367) | Inbella Medical, Inc. | 2025-10-15 |
| LOCATOR® Angled Abutment (K252944) | Zest Anchors, LLC | 2025-10-15 |
| ELEOS™ Limb Salvage System with NanoCept® Technology (K252920) | Onkos Surgical, Inc. | 2025-10-15 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (K250979) | Zoll Circulation, Inc. | 2025-10-15 |
| TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (K252020) | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| V-soft Line™ Barbed Surgical Suture (Various) (K250107) | Feeltech Co., Ltd. | 2025-10-15 |
| PressON Spinal Fixation System (K253331) | Nexus Spine | 2025-10-14 |
| Hemastyl(™) Wound Dressing (K250115) | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| Demi Pro (K253461) | Meta Systems Co., Ltd. | 2025-10-14 |
| Lithoblast Single Use Holmium Laser Fibers (K250776) | Dawell Medical, LLC | 2025-10-14 |
| Mini Superhawk Suture Anchor System (K253010) | Responsive Arthroscopy, LLC | 2025-10-14 |
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (K251874) | Pureway Compliance, Inc. | 2025-10-14 |
| IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) (K252234) | Shenzhen Qiaochengli Technology Co., Ltd. | 2025-10-14 |
| Community Containers (Flap and Daisy) (K252637) | Keter Canada, Inc. | 2025-10-14 |
| FlowArt® Vial Access Device Vented (K251715) | Asset Medikal | 2025-10-14 |