| K253738 — 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) Jan 23, 2026 |
| K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. Jan 23, 2026 |
| K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. Jan 23, 2026 |
| K250741 — Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited Jan 23, 2026 |
| K253652 — Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC Jan 22, 2026 |
| K252984 — Perin Health System (PHD80060-2) | Perin Health Devices, LLC Jan 22, 2026 |
| K251323 — Device 104 Particulate | Geistlich Pharma AG Jan 22, 2026 |
| K253735 — AV Vascular | Philips Medical Systems Nederland B.V. Jan 22, 2026 |
| K253057 — AI-Rad Companion Brain MR | Siemens Healthcare GmbH Jan 22, 2026 |
| K251511 — PhenoMATRIX | Copan Wasp Srl Jan 22, 2026 |
| K253498 — Pump In Style® Pro+ | Medela, LLC Jan 22, 2026 |
| K253253 — IPDmilled Blanks | Implant Protesis Dental 2004, S.L. Jan 22, 2026 |
| K253315 — Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG Jan 22, 2026 |
| K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. Jan 22, 2026 |
| K252307 — Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) Jan 22, 2026 |
| K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical Jan 22, 2026 |
| K251286 — Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Jan 21, 2026 |
| K254165 — Infinity OCT System | Medtronic Sofamor Danek USA, Inc. Jan 21, 2026 |
| K251281 — Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation Jan 21, 2026 |
| K260170 — LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. Jan 21, 2026 |
| K252369 — Boston Pico755 | Boston Aesthetics, Inc. Jan 21, 2026 |
| K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. Jan 21, 2026 |
| K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. Jan 21, 2026 |
| K252977 — Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. Jan 21, 2026 |
| K253730 — RoVo Mechanical Thrombectomy System | Verge Medical, Inc. Jan 21, 2026 |
| K251318 — VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. Jan 20, 2026 |
| K253698 — Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical Jan 20, 2026 |
| K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Jan 20, 2026 |
| K253998 — Clearview Intracoronary Shunts | Medtronic, Inc. Jan 20, 2026 |
| K253291 — Excelsior System | Blue Ocean Global Jan 20, 2026 |
| K253173 — uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Jan 20, 2026 |
| K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. Jan 20, 2026 |
| K252537 — Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. Jan 20, 2026 |
| K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health Jan 20, 2026 |
| K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. Jan 18, 2026 |
| K254114 — Baylis Connector Cable | Baylis Medical Technologies, Inc. Jan 18, 2026 |
| K253363 — NeuroSpan Bridge | Auxilium Biotechnologies, Inc. Jan 17, 2026 |
| K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland Jan 17, 2026 |
| K251448 — FL-10000U Respiratory Humidifier | Flexicare Medical Limited. Jan 16, 2026 |
| K252960 — SOLIUS PRO UVB Light Panel | Solius Labs, Inc. Jan 16, 2026 |
| K251341 — VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. Jan 16, 2026 |
| K251367 — OptoMonitor 3 | Opsens, Inc. Jan 16, 2026 |
| K254186 — Azurion R3.1 | Philips Medical Systems B.V. Jan 16, 2026 |
| K252767 — actiTENS mini | Sublimed Jan 16, 2026 |
| K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. Jan 16, 2026 |
| K251721 — Xpert GI Panel | Cepheid Jan 16, 2026 |
| K253082 — LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. Jan 16, 2026 |
| K250135 — WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical Jan 16, 2026 |
| K252297 — Toro 88 Superbore Catheter | Toro Neurovascular, Inc. Jan 16, 2026 |
| K251249 — Tru Hematology Test | Truvian Sciences, Inc. Jan 16, 2026 |