| K260537 — Willow 24 Guidewire | Arbor Endovascular, LLC Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260533 — ELISIO-H | Nipro Medical Corporation Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260532 — Derma-Gide | Geistlich Pharma AG Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260448 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253139 — Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253965 — CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260509 — AutoContour (RADAC V5) | Radformation, Inc. Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253012 — AlignRT Plus (8.0) | Vision Rt, Ltd. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253622 — Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252304 — syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253834 — VISUREF 600 | Carl Zeiss Vision GmbH Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254110 — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252961 — Fusion FibFix Nail | Fusion Orthopedics USA, LLC Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260188 — LimFlow Vector | LimFlow, Inc. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. Wed Mar 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253614 — EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250014 — Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253750 — BTL-785NEH | BTL Industries, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251926 — enCore Impression Material | Encore Guards Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252813 — Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253863 — GUARDIAN Quick Dip Residual Chlorine (5212) | Serim Research Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252078 — BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254167 — MDx-Chex for BCY | Streck, LLC Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260546 — Q Pedicle Instruments | K2m, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260390 — Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253886 — Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254053 — APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260632 — LASER THERMAL THERAPY KIT | Elesta S.P.A Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253587 — Cala kIQ Plus | Cala Health, Inc. Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252433 — Sonio Detect (v3) | Sonio Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253590 — Millipede System | Perfuze, Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253334 — ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260511 — Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252122 — DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252282 — SurgiCount+ System | Stryker Instruments Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253395 — Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253944 — Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254176 — SINEFIX | BAAT Medical Products B.V. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253838 — Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254079 — LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253705 — Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Technomed Europe Sun Mar 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |