| K260116 — CustoMED Viewer | CustoMED , Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261484 — Tissue Approximation System | Tas Medical, Inc. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260726 — Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261522 — BioWave BioWraps | Biowave Corporation Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260373 — Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260715 — CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260780 — HeartFocus | Deski Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252800 — KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253124 — Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253600 — Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260806 — Nitrile Disposable Examination Gloves | Vista Industries,, LLC Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254034 — Roosin Collagen Powder | Roosin Medical Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252854 — SteriTite Container System with MediTray Products | Case Medical, Inc. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261826 — VSP System (Titanium Palatal Splint) | 3D Systems, Inc. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260402 — MeRT System | Wave Neuroscience Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261840 — BracePaste Prime Plus | American Orthodontics Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252904 — SIC Abutments including CAD/CAM Solutions | Sic Invent AG Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253918 — Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260642 — Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261093 — DIAFIL | DiaDent Group International Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261002 — Pectus Blu System | Biomet Microfixation Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260364 — Device 300419 Strip | Geistlich Pharma AG Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252532 — Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252844 — Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260569 — DB 4000 High Impact Denture Base | Carbon, Inc. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261540 — Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253803 — MILAN System | Lumenis Be, Ltd. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253302 — Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253882 — CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. Mon Jun 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261541 — VisionAir Enhanced Stock Stent | VisionAir Solutions Mon Jun 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260456 — VI°Port Liver Preservation System | Traferox Technologies, Inc. Mon Jun 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261154 — CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC Sat May 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252947 — HistoSonics® Planning Tool | HistoSonics, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252965 — Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261038 — Xpert PFP | Newclip Technics Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252802 — Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261159 — Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253119 — CoSense ETCO Monitor | Capnia, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252859 — ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |