| K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253118 — Companion Spine DIAM Instrumentation | Companion Spine France Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252919 — IDENTIFY (5.0) | Varian Medical Systems, Inc. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251771 — Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253620 — TroClose 1200 | Gordian Surgical, Ltd. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251763 — IRISeg | Intuitive Surgical, Inc. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252204 — prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252111 — Versius Surgical System (Versius Plus) | Cmr Surgical Limited Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252940 — VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251893 — SKAN C PULSAR | Skanray Technologies Limited Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. Tue Dec 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251770 — SleepRes PAP System | Sleepres, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250319 — MFUSE (MS001) | Machina Medical, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253101 — HyperVue Imaging System - Integrated | Spectrawave, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252574 — Erchonia CLX (Model # CFL) | Erchonia Corporation Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252675 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253741 — VStick Vascular Access Set | Argon Medical Devices, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252950 — Paradigm System | Proprio, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253677 — Tembo Embolic System | Instylla, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253403 — FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. Mon Dec 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250851 — Hypnos (369054-200) | Cadwell Industries, Inc. Sun Dec 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250863 — FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252273 — Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253489 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252391 — Revi System | Bluewind Medical , Ltd. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250847 — VaporShield | Vault Paragon Group, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253749 — Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253609 — TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251177 — Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252090 — Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252745 — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250974 — Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250488 — Cerynë Intimate Care | Ansella Therapeutics Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242817 — Jason membrane | Botiss Biomaterials GmbH Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |