| K251577 — LAIA XR | Augmented Reality Software S.L. Feb 6, 2026 |
| K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. Feb 6, 2026 |
| K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH Feb 6, 2026 |
| K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG Feb 6, 2026 |
| K251474 — Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies Feb 6, 2026 |
| K251836 — Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. Feb 6, 2026 |
| K243979 — Aptiva APS IgA Reagent | Inova Diagnostics, Inc. Feb 6, 2026 |
| K253927 — LiveMedica Enterprise PACS | Live Medica, LLC Feb 6, 2026 |
| DEN250006 — Amferia Wound Dressing | Amferia AB Feb 6, 2026 |
| K251507 — INTEGRE LIO | Quantel Medical Feb 6, 2026 |
| K251423 — Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. Feb 6, 2026 |
| K252076 — Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. Feb 6, 2026 |
| K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited Feb 6, 2026 |
| K253780 — SIGNA Bolt | Ge Medical Systems, LLC Feb 6, 2026 |
| K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. Feb 5, 2026 |
| K253779 — SIGNA Sprint Select | Ge Medical Systems, LLC Feb 5, 2026 |
| K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. Feb 5, 2026 |
| K251517 — Encora X1 | Encora, Inc. Feb 5, 2026 |
| K253959 — Primevision 3D | Dentsply Sirona Feb 5, 2026 |
| K260012 — UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. Feb 4, 2026 |
| K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. Feb 4, 2026 |
| K260038 — E3D-C Interbody System | Evolution Spine Feb 4, 2026 |
| K250773 — Luna® Ti Interbody Fusion System | Spinal Elements, Inc. Feb 4, 2026 |
| K252623 — G7® Revision Acetabular System | Zimmer, Inc. Feb 4, 2026 |
| K260104 — Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer CAS Feb 4, 2026 |
| K252438 — Explant Express | Applied Medical Technology, Inc. Feb 3, 2026 |
| K250644 — MSS - Monobloc stem | Medacta International S.A. Feb 3, 2026 |
| K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. Feb 3, 2026 |
| K252676 — The Circadia C300 System (C300) | Circadia Health, Inc. Feb 3, 2026 |
| K253701 — SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed Feb 3, 2026 |
| K252909 — Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. Feb 3, 2026 |
| K252048 — 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. Feb 3, 2026 |
| K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH Feb 3, 2026 |
| K252087 — Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. Feb 3, 2026 |
| K253282 — ZSmile System | Dror Orthodesign , Ltd. Feb 3, 2026 |
| K251200 — Vital Signs | Oxehealth Limited Feb 2, 2026 |
| K252649 — TAP2D | Nano-X Imaging , Ltd. Feb 2, 2026 |
| K252011 — CHIKAI Nexus petit | Asahi Intecc Co., Ltd. Feb 2, 2026 |
| K252286 — BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. Feb 2, 2026 |
| K251582 — Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. Feb 2, 2026 |
| K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. Jan 31, 2026 |
| K253671 — Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. Jan 30, 2026 |
| K254305 — BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. Jan 30, 2026 |
| K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group Jan 30, 2026 |
| K254283 — BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. Jan 30, 2026 |
| K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal Jan 30, 2026 |
| K251981 — Boston PICO (Boston PICO) | Boston Aesthetics, Inc. Jan 30, 2026 |
| K252457 — Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. Jan 30, 2026 |
| K251407 — Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. Jan 30, 2026 |
| K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. Jan 30, 2026 |