| K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260320 — Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254248 — Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260976 — NeuroBlate System | Monteris Medical Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253752 — ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260152 — Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260785 — DS Core CBCT Anatomy | Dentsply Sirona Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260947 — 0.55T 12Ch Breast Coil | Neocoil, LLC Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254237 — CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253589 — Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252815 — ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. Thu Apr 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260237 — Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253765 — VANISH PRO | Ddc Technologies, Inc. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260570 — corra cervical plating system | Carlsmed, Inc. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253077 — uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260150 — LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260239 — Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. Wed Apr 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260573 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253982 — Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250793 — RhythmStar System (SL) | RhythMedix, LLC Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254046 — BosCATH Support Catheter | Sonorous NV, Inc. Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253213 — SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253638 — xStep (xStep) | Spinex, Inc. Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252718 — Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253558 — Luminoah FLOW Enteral Nutrition System | Luminoah Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260153 — Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260212 — EnSite X EP System | ABBOTT MEDICAL Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252332 — Folliscan | Mim Fertility Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242163 — SmartSurgN Visualization System | SmartsurgN, Inc. Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253806 — Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252945 — Novasight Hybrid System | Conavi Medical, Inc. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250033 — XplantR Explant Tool | Hjarta Care, LLC Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252338 — MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260900 — DYNEX® External Fixation Systems | Vilex, LLC Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254279 — Edwards eSheath+ introducer set | Edwards Lifesciences Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261261 — Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |