| K260380 — Mendit | Escala Medical, Ltd. Mar 4, 2026 |
| K252534 — Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. Mar 3, 2026 |
| K254245 — ZAFIRA® | New Stetic, SA Mar 3, 2026 |
| K251940 — PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. Mar 3, 2026 |
| K260682 — Bond-PR Universal Adhesive | Premier Dental Products Company Mar 3, 2026 |
| K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. Mar 3, 2026 |
| K253874 — LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. Mar 3, 2026 |
| K260010 — TMINI® Miniature Robotic System | THINK Surgical, Inc. Mar 3, 2026 |
| K253920 — CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. Mar 3, 2026 |
| K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. Mar 3, 2026 |
| K253818 — Annalise Enterprise | Harrison-AI Medical Pty, Ltd. Mar 3, 2026 |
| K251793 — SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. Mar 3, 2026 |
| K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. Mar 2, 2026 |
| K253593 — Clarius Ejection Fraction AI | Clarius Mobile Health Corp. Mar 2, 2026 |
| K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. Mar 2, 2026 |
| K260003 — KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG Mar 2, 2026 |
| K253380 — FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. Mar 2, 2026 |
| K254229 — Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. Mar 2, 2026 |
| K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. Mar 2, 2026 |
| K253798 — UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. Mar 2, 2026 |
| K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH Mar 2, 2026 |
| K252632 — Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. Mar 2, 2026 |
| K251777 — MESI mTABLET SPIRO | Mesi D.O.O. Mar 2, 2026 |
| K253535 — Ligence Heart | Ligence Uab Feb 27, 2026 |
| K253828 — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. Feb 27, 2026 |
| K253695 — LigaMend | Riverpoint Medical, LLC Feb 27, 2026 |
| K252714 — C-Lant Port | Vigor Medical Technologies , Ltd. Feb 27, 2026 |
| K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. Feb 27, 2026 |
| K254249 — HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. Feb 27, 2026 |
| K253778 — Allday Moisturizing Rinse | Elevate Oral Care Feb 27, 2026 |
| K252448 — AViTA Pulse Oximeter (SP61) | Avita Corporation Feb 27, 2026 |
| K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. Feb 27, 2026 |
| K253536 — Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. Feb 27, 2026 |
| K253797 — One-Stop | Mediclus Co., Ltd. Feb 27, 2026 |
| K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical Feb 27, 2026 |
| K253641 — Owl Night Guard | Owl Dental Lab, Inc. Feb 26, 2026 |
| K254017 — SWINGO-3D Lumbar Cage System | Implanet Feb 26, 2026 |
| K252166 — RIB LINK Fixation System | Globus Medical, Inc. Feb 26, 2026 |
| K253328 — GMK 3D Metal Tibial Tray Extension | Medacta International S.A. Feb 26, 2026 |
| K254182 — Aster | Osteonic Co., Ltd. Feb 26, 2026 |
| K251860 — Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. Feb 26, 2026 |
| K260254 — Enbio PRO | Enbio Group AG Feb 26, 2026 |
| K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | Speciality Fibres And Materials Limited Feb 26, 2026 |
| K253791 — PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. Feb 26, 2026 |
| K254251 — InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. Feb 26, 2026 |
| K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. Feb 26, 2026 |
| K254271 — CAPRI | ORO Co., Ltd. Feb 26, 2026 |
| K253021 — ANNE Maternal | Sibel Health, Inc. Feb 26, 2026 |
| K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG Feb 26, 2026 |
| K253764 — ENOS Software Guided External Fixation System | Disior, Ltd. Feb 26, 2026 |