| K252961 — Fusion FibFix Nail | Fusion Orthopedics USA, LLC Mar 18, 2026 |
| K260188 — LimFlow Vector | LimFlow, Inc. Mar 18, 2026 |
| K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. Mar 18, 2026 |
| K253863 — GUARDIAN Quick Dip Residual Chlorine (5212) | Serim Research Mar 17, 2026 |
| K252078 — BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. Mar 17, 2026 |
| K253614 — EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. Mar 17, 2026 |
| K251926 — enCore Impression Material | Encore Guards Mar 17, 2026 |
| K254167 — MDx-Chex for BCY | Streck, LLC Mar 17, 2026 |
| DEN250014 — Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. Mar 17, 2026 |
| K253750 — BTL-785NEH | BTL Industries, Inc. Mar 17, 2026 |
| K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. Mar 17, 2026 |
| K252813 — Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. Mar 17, 2026 |
| K260546 — Q Pedicle Instruments | K2M, Inc. Mar 17, 2026 |
| K260390 — Super Upper Limbs Versalock Plating System | GM Dos Reis Industria E Comercio Ltda. Mar 17, 2026 |
| K253886 — Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. Mar 17, 2026 |
| K254053 — APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. Mar 17, 2026 |
| K260632 — LASER THERMAL THERAPY KIT | Elesta S.P.A Mar 17, 2026 |
| K253587 — Cala kIQ Plus | Cala Health, Inc. Mar 17, 2026 |
| K253395 — Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. Mar 16, 2026 |
| K253590 — Millipede System | Perfuze, Ltd. Mar 16, 2026 |
| K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. Mar 16, 2026 |
| K252433 — Sonio Detect (v3) | Sonio Mar 16, 2026 |
| K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG Mar 16, 2026 |
| K260511 — Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. Mar 16, 2026 |
| K252122 — DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. Mar 16, 2026 |
| K253944 — Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated Mar 16, 2026 |
| K253334 — ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. Mar 16, 2026 |
| K252282 — SurgiCount+ System | Stryker Instruments Mar 16, 2026 |
| K254176 — SINEFIX | BAAT Medical Products B.V. Mar 16, 2026 |
| K253838 — Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. Mar 16, 2026 |
| K254079 — LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. Mar 16, 2026 |
| K253705 — Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC Mar 16, 2026 |
| K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. Mar 16, 2026 |
| 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 Mar 15, 2026 |
| K252923 — IASIS i2 Relaxation Neurofeedback System | Iasis Technologies Mar 13, 2026 |
| K252249 — Extremity CT Imaging System | Mars Bioimaging , Ltd. Mar 13, 2026 |
| K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC Mar 13, 2026 |
| K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. Mar 13, 2026 |
| K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson And Company Mar 13, 2026 |
| K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation Mar 13, 2026 |
| K251999 — Promogran Prisma Collagen Matrix with ORC and Silver | Solventum Germany GmbH Mar 13, 2026 |
| K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. Mar 13, 2026 |
| K253261 — Apollo Quattro (APQ-10M) | Weero Co., Ltd. Mar 13, 2026 |
| K253111 — Aeka Imaging | Good Methods Global, Inc. Mar 13, 2026 |
| K260499 — Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL Mar 13, 2026 |
| K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. Mar 13, 2026 |
| K260078 — Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation Mar 13, 2026 |
| K252261 — InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. Mar 13, 2026 |
| K260479 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Mar 13, 2026 |
| K253987 — BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical Mar 13, 2026 |