| K260570 — corra cervical plating system | Carlsmed, Inc. Apr 22, 2026 |
| K253765 — VANISH PRO | Ddc Technologies, Inc. Apr 22, 2026 |
| K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH Apr 22, 2026 |
| K260237 — Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry And Trade Co., Ltd. Apr 22, 2026 |
| K253077 — uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. Apr 22, 2026 |
| K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH Apr 22, 2026 |
| K252306 — Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | Steritec Products Apr 22, 2026 |
| K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. Apr 22, 2026 |
| K260150 — LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE Apr 22, 2026 |
| K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical Apr 21, 2026 |
| K253982 — Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. Apr 21, 2026 |
| K250793 — RhythmStar System (SL) | RhythMedix, LLC Apr 21, 2026 |
| K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. Apr 21, 2026 |
| K260518 — IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd. Apr 21, 2026 |
| K260573 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Apr 21, 2026 |
| K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA Apr 21, 2026 |
| K254046 — BosCATH Support Catheter | Sonorous NV, Inc. Apr 21, 2026 |
| K253213 — SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Apr 20, 2026 |
| K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. Apr 20, 2026 |
| K253806 — Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Apr 20, 2026 |
| K242163 — SmartSurgN Visualization System | SmartsurgN, Inc. Apr 20, 2026 |
| K260212 — EnSite X EP System | ABBOTT MEDICAL Apr 20, 2026 |
| K252718 — Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Apr 20, 2026 |
| K253558 — Luminoah FLOW Enteral Nutrition System | Luminoah Apr 20, 2026 |
| K253638 — xStep (xStep) | Spinex, Inc. Apr 20, 2026 |
| K252332 — Folliscan | Mim Fertility Apr 20, 2026 |
| K260153 — Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. Apr 20, 2026 |
| K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag Apr 17, 2026 |
| K252338 — MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) Apr 17, 2026 |
| K252945 — Novasight Hybrid System | Conavi Medical, Inc. Apr 17, 2026 |
| DEN250033 — XplantR Explant Tool | Hjarta Care, LLC Apr 17, 2026 |
| K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. Apr 17, 2026 |
| K260900 — DYNEX® External Fixation Systems | Vilex, LLC Apr 17, 2026 |
| K254279 — Edwards eSheath+ introducer set | Edwards Lifesciences Apr 17, 2026 |
| K261261 — Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. Apr 17, 2026 |
| K253970 — Wovyn Depth Electrode | Sensomedical Labs, Ltd. Apr 17, 2026 |
| K260934 — TITAN Nail; APTUS K-Wire System | Medartis AG Apr 17, 2026 |
| K260929 — Neonav ECG Tip Location System | Navi Medical Technologies Apr 17, 2026 |
| K252237 — EdgeFlow UW20 | Edgecare, Inc. Apr 17, 2026 |
| K260696 — MTS Gepotidacin 0.016-256 µg/mL | Liofilchem S.R.L. Apr 17, 2026 |
| K252317 — Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited Apr 16, 2026 |
| K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 16, 2026 |
| K254216 — Enso for Migraine | Hinge Health, Inc. Apr 16, 2026 |
| K253907 — Disposable Radiofrequency Cannula | ABBOTT MEDICAL Apr 16, 2026 |
| K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. Apr 16, 2026 |
| K253260 — ORIO-3D Cage System | SpineCraft Apr 16, 2026 |
| K251658 — Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH Apr 16, 2026 |
| K253804 — DESS Dental Smart Solutions | Terrats Medical SL Apr 16, 2026 |
| K260020 — Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. Apr 16, 2026 |
| K260903 — Hot Pink Pad Warming System | Xodus Medical, Inc. Apr 16, 2026 |