| K252073 — VOCO Profluorid Varnish + BioMin | Voco GmbH Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252488 — ABL90 FLEX PLUS System | Radiometer Medicals Aps Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252439 — Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253326 — Oxiplex | Fziomed, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254154 — FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254077 — OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261074 — BIOMONITOR IV (471155) | Biotronik, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252635 — ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252475 — ABL90 FLEX PLUS System | Radiometer Medicals Aps Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253663 — Zeta Navigation System | Zeta Surgical, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240075 — Prolystica Pass Thru Disinfectant Wipes | Steris Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260314 — Ancora-SB | Aspero Medical, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260910 — EndoTool IV Cloud 1.0 | Glooko, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261045 — Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260819 — Any-Com Seal | Mediclus Co., Ltd. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254139 — BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254234 — Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252849 — AffloVest® Mobile Airway Clearance Therapy | Tactile Medical Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253976 — iLet ACE Pump | Beta Bionics, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253064 — Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252455 — FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252858 — 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260342 — AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250680 — Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252503 — Intelligent NR | Canon, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261067 — BEE PLIF Cage | NGMedical GmbH Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261404 — UltraEZ | Ultradent Products, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251583 — Ambu® Virobac II® Exhalation Filter | Ambu A/S Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250023 — Aurie System | Cathbuddy, Inc. Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254189 — Synapse 3D Base Tools (V7.2) | Fujifilm Corporation Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253436 — c-med0 alpha | Cosinuss GmbH Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261086 — Break Wave | Sonomotion, Inc. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254184 — syngo Application Software | Siemens Medical Solutions USA, Inc. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260589 — ES-Series | E-Scopics Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260606 — Echo Large Bore Introducer Sheath | Echo Medical, LLC Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261094 — YellowStar | Asclepion Laser Technologies GmbH Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252471 — Paptizer 360 | LiViliti Health Products Corporation Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252542 — LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253682 — DeepHealth ProstateAI | Quantib B.V. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253401 — SCRIPT Implant System | Globus Medical, Inc. Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |