| K253701 — SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252011 — CHIKAI Nexus petit | Asahi Intecc Co., Ltd. Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252649 — TAP2D | Nano-X Imaging , Ltd. Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252286 — BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251200 — Vital Signs | Oxehealth Limited Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251582 — Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. Sat Jan 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254283 — BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252457 — Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253318 — Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254305 — BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251981 — Boston PICO (Boston PICO) | Boston Aesthetics, Inc. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251769 — RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251407 — Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253671 — Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251427 — EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252349 — Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243732 — Multi-Unit DAS System | Talladium España, SL Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252091 — Surgical Reality Viewer | Medicalvr B.V. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253763 — Y-Knotless Flex Anchors | Conmed Corporation Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251923 — Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252684 — Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253611 — Falco Fusion System | Mcnicoll Surgical, Inc. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252496 — Neurophet AQUA AD Plus | Neurophet., Inc. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252347 — Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253632 — Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252275 — Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251354 — UV Smart D60 | UV Smart Technologies B.V. Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251896 — XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251347 — Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252834 — Sacroiliac Joint Truss System (SJTS) | 4Web Medical Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253842 — Vena MicroAngioscope System | Vena Medical Holdings Corp Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253388 — Sleepiz One+ (Model 2.5) | Sleepiz AG Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260004 — Aevumed PROTEKT Suture Anchor | Aevumed, Inc. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251622 — Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252164 — NorthStar Mapping System | Imricor Medical Systems Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253254 — GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251306 — Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251043 — Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252603 — HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254220 — Reusable 3 Button Fingerswitch Wand | Soniquence, LLC Tue Jan 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251435 — InbellaIgnite RF System | Inbella Medical, Inc. Tue Jan 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254221 — Optima Coil System (OptiOne Coil System) | Balt USA, LLC Tue Jan 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |