| K253318 — Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. Jan 30, 2026 |
| K251769 — RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx Jan 30, 2026 |
| K252275 — Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. Jan 29, 2026 |
| K252349 — Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. Jan 29, 2026 |
| K251923 — Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. Jan 29, 2026 |
| K252684 — Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. Jan 29, 2026 |
| K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC Jan 29, 2026 |
| K252091 — Surgical Reality Viewer | Medicalvr B.V. Jan 29, 2026 |
| K253763 — Y-Knotless Flex Anchors | Conmed Corporation Jan 29, 2026 |
| K253611 — Falco Fusion System | Mcnicoll Surgical, Inc. Jan 29, 2026 |
| K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare Jan 29, 2026 |
| K243732 — Multi-Unit DAS System | Talladium España, SL Jan 29, 2026 |
| K251427 — EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. Jan 29, 2026 |
| K253632 — Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Jan 29, 2026 |
| K252347 — Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. Jan 29, 2026 |
| K252496 — Neurophet AQUA AD Plus | Neurophet., Inc. Jan 29, 2026 |
| K251354 — UV Smart D60 | UV Smart Technologies B.V. Jan 29, 2026 |
| K251306 — Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. Jan 28, 2026 |
| K253254 — GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A Jan 28, 2026 |
| K251896 — XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. Jan 28, 2026 |
| K251622 — Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. Jan 28, 2026 |
| K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. Jan 28, 2026 |
| K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited Jan 28, 2026 |
| K260004 — Aevumed PROTEKT Suture Anchor | Aevumed, Inc. Jan 28, 2026 |
| K252603 — HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jan 28, 2026 |
| K251043 — Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. Jan 28, 2026 |
| K251347 — Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. Jan 28, 2026 |
| K252164 — NorthStar Mapping System | Imricor Medical Systems Jan 28, 2026 |
| K252834 — Sacroiliac Joint Truss System (SJTS) | 4Web Medical Jan 28, 2026 |
| K253388 — Sleepiz One+ (Model 2.5) | Sleepiz AG Jan 28, 2026 |
| K253842 — Vena MicroAngioscope System | Vena Medical Holdings Corp Jan 28, 2026 |
| K254220 — Reusable 3 Button Fingerswitch Wand | Soniquence, LLC Jan 27, 2026 |
| K251195 — BriefCase-Triage | Aidoc Medical , Ltd. Jan 27, 2026 |
| K251995 — Access anti-HAV IgM | Beckman Coulter, Inc. Jan 27, 2026 |
| K251435 — InbellaIgnite RF System | Inbella Medical, Inc. Jan 27, 2026 |
| K254221 — Optima Coil System (OptiOne Coil System) | Balt USA, LLC Jan 27, 2026 |
| K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. Jan 26, 2026 |
| K251670 — MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. Jan 26, 2026 |
| K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. Jan 26, 2026 |
| K252753 — Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda Jan 24, 2026 |
| K253633 — Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Jan 24, 2026 |
| K252957 — Pneumo Dissector Hook | Ab Medica Sas Jan 23, 2026 |
| K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. Jan 23, 2026 |
| K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jan 23, 2026 |
| K251351 — AccuContour 4.0 | Manteia Technologies Co., Ltd. Jan 23, 2026 |
| K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. Jan 23, 2026 |
| K253160 — Syntex Exam Gloves | Basic Medical Technology, Inc. Jan 23, 2026 |
| K253285 — Elitone for Men | Elidah, Inc. Jan 23, 2026 |
| K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. Jan 23, 2026 |
| K252568 — New Day Skin Spray | Silk Holdings, Inc. Jan 23, 2026 |