| K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Jan 7, 2026 |
| K253158 — VyBrate VBR System | Vy Spine, LLC Jan 7, 2026 |
| K252507 — SmileInspector | Amv Consulting, LLC Jan 7, 2026 |
| K253009 — DS Core Detect | Dentsply Sirona, Inc. Jan 7, 2026 |
| K253923 — PuraStat | 3-D Matrix Europe SAS Jan 7, 2026 |
| K252970 — BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. Jan 7, 2026 |
| K251454 — Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited Jan 7, 2026 |
| K252890 — ZenSeal Pro | Kerr Corporation Jan 7, 2026 |
| K252886 — Pen Needle | Hh Global Technology, Inc. Jan 6, 2026 |
| K253618 — QuadLock Fixation System | Abanza Tecnomed S.L Jan 6, 2026 |
| K251097 — V-DAC Catheter | Vesalio, Inc. Jan 6, 2026 |
| K250341 — Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. Jan 6, 2026 |
| K253178 — TRILEAP Plating System | Crossroads Extremity Systems Jan 6, 2026 |
| K252749 — Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. Jan 6, 2026 |
| K251165 — Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited Jan 6, 2026 |
| K253793 — Materialise TKA Guide System | Materialise NV Jan 6, 2026 |
| K252894 — aprevo® cervical interbody system | Carlsmed, Inc. Jan 6, 2026 |
| K251630 — Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. Jan 5, 2026 |
| K252988 — ChartCheck (RADCH V1.6) | Radformation, Inc. Jan 5, 2026 |
| K252650 — Disposable Medical Face Mask | Makrite Industries, Inc. Jan 5, 2026 |
| K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Jan 5, 2026 |
| K251757 — Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. Jan 5, 2026 |
| K253008 — maiLink | Maihub Corp. Jan 5, 2026 |
| K251668 — SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. Jan 5, 2026 |
| K253867 — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG Jan 2, 2026 |
| K252817 — Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. Jan 2, 2026 |
| K251178 — Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation Jan 2, 2026 |
| K253854 — MONTAGE XT Cranial Cement | Orthocon, Inc. Jan 2, 2026 |
| K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. Dec 31, 2025 |
| K252901 — Tyber Medical Trauma Screw | Tyber Medical, LLC Dec 31, 2025 |
| K252951 — Genesis Sleep | Neurofield, Inc. Dec 31, 2025 |
| K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC Dec 31, 2025 |
| K253888 — MOLLI 2 System | Stryker Endoscopy Dec 31, 2025 |
| K251091 — Lipids | Truvian Health Dec 30, 2025 |
| K253844 — AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. Dec 30, 2025 |
| K242492 — Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | Techno-Path Manufacturing , Ltd. Dec 30, 2025 |
| K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. Dec 30, 2025 |
| K253532 — TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. Dec 30, 2025 |
| K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare Dec 30, 2025 |
| K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | Covidien, LLC Dec 29, 2025 |
| K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. Dec 29, 2025 |
| K253325 — ZipToe Hammertoe Fusion System | Toetal Solutions Dec 29, 2025 |
| K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science And Technology Co., Ltd. Dec 29, 2025 |
| K253343 — Celebrace Software | Celebrace Dec 29, 2025 |
| K251534 — Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. Dec 29, 2025 |
| K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC Dec 29, 2025 |
| K253349 — Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. Dec 24, 2025 |
| K253342 — PICO-K | Speclipse, Inc. Dec 24, 2025 |
| K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. Dec 24, 2025 |
| K253279 — Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC Dec 24, 2025 |