| K251515 — Solidex® Ti-Links and Screws | CreoDent Hudson Valley Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252751 — Earflo (EF001) | Earflo, Inc. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254016 — MI View&GO | Siemens Medical Solutions USA, Inc. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252175 — LANDR Contact LENS Case | Fourth Axis, LLC Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260119 — SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254033 — Ceribell Instant EEG Headset | Ceribell, Inc. Mon Feb 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251591 — Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. Mon Feb 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254236 — Peel-Away Introducer Sheath | VascuTech Medical, LLC Mon Feb 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251507 — INTEGRE LIO | Quantel Medical Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243348 — Athelas Home | Athelas, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253780 — SIGNA Bolt | Ge Medical Systems, LLC Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252873 — Q Interbody Instruments | K2m, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253927 — LiveMedica Enterprise PACS | Live Medica, LLC Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252076 — Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251218 — SafeBeat Rx App | Safebeat Rx, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251474 — Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250006 — Amferia Wound Dressing | Amferia AB Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243979 — Aptiva APS IgA Reagent | Inova Diagnostics, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251836 — Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251423 — Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | Ethicon, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251577 — LAIA XR | Augmented Reality Software S.L. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251614 — Stainless Steel Surgical Kits | Dentsply Sirona, Inc. Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253779 — SIGNA Sprint Select | Ge Medical Systems, LLC Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253959 — Primevision 3D | Dentsply Sirona Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251517 — Encora X1 | Encora, Inc. Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250773 — Luna® Ti Interbody Fusion System | Spinal Elements, Inc. Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260104 — Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252623 — G7® Revision Acetabular System | Zimmer, Inc. Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260012 — UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260038 — E3D-C Interbody System | Evolution Spine Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252909 — Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250644 — MSS - Monobloc stem | Medacta International S.A. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252048 — 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252676 — The Circadia C300 System (C300) | Circadia Health, Inc. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252438 — Explant Express | Applied Medical Technology, Inc. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253282 — ZSmile System | Dror Orthodesign , Ltd. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252087 — Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |