| K261775 — Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. Jul 21, 2026 |
| K260500 — ResolutionMD | ResolutionMD, Inc. Jul 21, 2026 |
| K260591 — NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical Jul 21, 2026 |
| K261738 — Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. Jul 21, 2026 |
| K261728 — One-Fil LC | Mediclus Co., Ltd. Jul 21, 2026 |
| K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. Jul 21, 2026 |
| K253814 — Raney Clips Kit | Beijing Honghugaoxiang Science And Technology Development CO Jul 21, 2026 |
| K253770 — CardIQ Suite | GE Medical Systems SCS Jul 21, 2026 |
| DEN250068 — OTTAVA Robotic Surgical System | Auris Health, Inc., Part Of Johnson & Johnson MedTech Jul 21, 2026 |
| K261535 — Hi-D Imaging 4TAVR | Hi-D Imaging AG Jul 20, 2026 |
| K261573 — ENDOSCOPE HOLDER (182214) | Aktormed GmbH Jul 20, 2026 |
| K254285 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue | Hartalega NGC Sdn. Bhd. Jul 20, 2026 |
| K261632 — Thunderbolt System | Responsive Arthroscopy, Inc. Jul 20, 2026 |
| K261011 — Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. Jul 20, 2026 |
| K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | MacroLux Medical Technology Co., Ltd. Jul 20, 2026 |
| K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | Taiwan Surgical Corporation Jul 20, 2026 |
| K251952 — Virasight | Virasoft Corporation Jul 17, 2026 |
| K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine Jul 17, 2026 |
| K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC Jul 17, 2026 |
| K253694 — Natural Cycles | Natural Cycles Nordic AB Jul 17, 2026 |
| K253011 — Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. Jul 17, 2026 |
| DEN250040 — SportSuite Vision Software | Stryker Endoscopy Jul 17, 2026 |
| K261046 — Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. Jul 17, 2026 |
| K261658 — LoFric Origo Pro Coudé | Wellspect AB Jul 17, 2026 |
| K253963 — Cubresa BrainPET | Cubresa, Inc. Jul 17, 2026 |
| K260694 — ZEISS CLINIC 360 | Carl Zeiss Meditec, AG Jul 17, 2026 |
| K261693 — Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. Jul 17, 2026 |
| K261614 — LED LCD Monitor (OEV-271H) | Lg Electronics.Inc Jul 17, 2026 |
| K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. Jul 17, 2026 |
| K254006 — Drivewire 35 Guidewire | Rapid Medical Ltd. Jul 17, 2026 |
| K261984 — AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Jul 17, 2026 |
| K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. Jul 16, 2026 |
| K261309 — Palisades Buttress Plate System | Bethesda Medical Devices, LLC Jul 16, 2026 |
| K260021 — cobas® BV/CV | Roche Molecular Systems, Inc. Jul 16, 2026 |
| K261271 — Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. Jul 16, 2026 |
| K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. Jul 16, 2026 |
| K261674 — Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. Jul 16, 2026 |
| K261706 — Endomat Select (UP220) | KARL STORZ SE & CO. KG Jul 16, 2026 |
| K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. Jul 15, 2026 |
| K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. Jul 15, 2026 |
| K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. Jul 15, 2026 |
| K260338 — ThinkSono Guidance | ThinkSono GmbH Jul 15, 2026 |
| K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. Jul 15, 2026 |
| K260851 — Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. Jul 15, 2026 |
| K260739 — Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. Jul 15, 2026 |
| K260050 — WRAP System | Huneo, LLC Jul 15, 2026 |
| K260206 — SkeletonPlanner | UPlanner B.V. - Presurgeo Jul 15, 2026 |
| K262030 — Aventus Thrombectomy System | Inquis Medical Jul 15, 2026 |
| K262006 — EnSite X EP System | Abbott Medical Jul 15, 2026 |
| K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S Jul 14, 2026 |