| K252507 — SmileInspector | Amv Consulting, LLC Jan 7, 2026 |
| K253366 — LOGIQ Fortis | GE Medical Systems Ultrasound And Primary Care Diagnostics Jan 7, 2026 |
| K253924 — PuraStat | 3-D Matrix Europe SAS Jan 7, 2026 |
| K253009 — DS Core Detect | Dentsply Sirona, Inc. Jan 7, 2026 |
| K252970 — BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. Jan 7, 2026 |
| K253939 — DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. Jan 7, 2026 |
| K252890 — ZenSeal Pro | Kerr Corporation Jan 7, 2026 |
| K251454 — Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited Jan 7, 2026 |
| K253178 — TRILEAP Plating System | Crossroads Extremity Systems Jan 6, 2026 |
| K253618 — QuadLock Fixation System | Abanza Tecnomed S.L Jan 6, 2026 |
| K252894 — aprevo® cervical interbody system | Carlsmed, Inc. Jan 6, 2026 |
| K251097 — V-DAC Catheter | Vesalio, Inc. 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 |
| K252749 — Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. Jan 6, 2026 |
| K252886 — Pen Needle | Hh Global Technology, Inc. Jan 6, 2026 |
| K250341 — Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. Jan 6, 2026 |
| K252650 — Disposable Medical Face Mask | Makrite Industries, Inc. Jan 5, 2026 |
| K252988 — ChartCheck (RADCH V1.6) | Radformation, Inc. Jan 5, 2026 |
| K251668 — SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. Jan 5, 2026 |
| K251757 — Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. Jan 5, 2026 |
| K251630 — Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. Jan 5, 2026 |
| K253008 — maiLink | Maihub Corp. 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 |
| K253854 — MONTAGE XT Cranial Cement | Orthocon, Inc. Jan 2, 2026 |
| K252817 — Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. Jan 2, 2026 |
| K253867 — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG Jan 2, 2026 |
| K251178 — Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation Jan 2, 2026 |