| K252168 — Straumann® BLC Implants - Indication Widening | Institut Straumann AG Mar 10, 2026 |
| K253953 — IPS e.max Zirconia | Ivoclar Vivadent, Inc. Mar 10, 2026 |
| K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Mar 9, 2026 |
| K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. Mar 9, 2026 |
| K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. Mar 9, 2026 |
| K252888 — NeoSculpt Plus | S&M Medical Co., Ltd. Mar 9, 2026 |
| K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC Mar 9, 2026 |
| K260405 — FiberTape Button | Arthrex, Inc. Mar 9, 2026 |
| K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH Mar 9, 2026 |
| K253960 — Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD Mar 9, 2026 |
| K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation Mar 9, 2026 |
| K253413 — LiverMultiScan (v6.0) | Perspectum, Ltd. Mar 9, 2026 |
| K253668 — Onera SleepMap (SLEEPMAP) | Onera B.V. Mar 8, 2026 |
| K253551 — VELYS Hip Navigation | Depuy Ireland UC Mar 6, 2026 |
| K253262 — EmeryGlide (EG18008901) | Nano4Imaging GmbH Mar 6, 2026 |
| K253132 — Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. Mar 6, 2026 |
| K253772 — Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG Mar 6, 2026 |
| K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. Mar 6, 2026 |
| K253538 — TeKBrace Knotless Anchor | Theramicro Mar 6, 2026 |
| K253983 — Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. Mar 6, 2026 |
| K260361 — Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. Mar 6, 2026 |
| K260167 — Bunkerhill Contrast AVC | BunkerHill Health Mar 6, 2026 |
| K260013 — CVAC Image Processor | Calyxo, Inc. Mar 6, 2026 |
| K252208 — JFord Speculum Sleeve | Ford Medtech, LLC Mar 6, 2026 |
| K260166 — Bunkerhill Contrast CAC | BunkerHill Health Mar 6, 2026 |
| K253951 — Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mar 6, 2026 |
| K251818 — BONTREE PLUS | Hudens Bio Co., Ltd. Mar 6, 2026 |
| K260169 — AV Cardiac CT | Philips Medical Systems Nederland B.V. Mar 5, 2026 |
| K252538 — CEPHX3D | Orca Dental AI , Ltd. Mar 5, 2026 |
| K253591 — Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. Mar 5, 2026 |
| K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Mar 5, 2026 |
| K251788 — Extension tube | Zhuhai DR Medical Instruments Co., Ltd. Mar 5, 2026 |
| K253442 — EarliPoint Assessment | Earlitec Diagnostics Mar 5, 2026 |
| K253267 — CORIS System | Nanosonics Limited Mar 5, 2026 |
| K252196 — Arthrex FibuLock Nail System | Arthrex, Inc. Mar 5, 2026 |
| K251901 — Magnifico Open (100009900) | Esaote, S.P.A. Mar 5, 2026 |
| K252450 — Adhese 2 | Ivoclar Vivadent, Inc. Mar 5, 2026 |
| K253898 — QT Scanner 2000 Model A | QT Imaging Holdings, Inc. Mar 4, 2026 |
| K253896 — TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. Mar 4, 2026 |
| K251434 — Healing Abutment System | Osstem Implant Co., Ltd. Mar 4, 2026 |
| K253871 — Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC Mar 4, 2026 |
| K260015 — ANTERIS Thoracolumbar Plate System | SpineCraft Mar 4, 2026 |
| K253493 — Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. Mar 4, 2026 |
| K254306 — Aevumed FENIX Suture Anchor | Aevumed, Inc. Mar 4, 2026 |
| K253870 — Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd Mar 4, 2026 |
| K252025 — Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. Mar 4, 2026 |
| K253565 — SureSmile Software | Dentsply Sirona, Inc. Mar 4, 2026 |
| K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Mar 4, 2026 |
| K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. Mar 4, 2026 |
| DEN250012 — LifeVac | Lifevac, LLC Mar 4, 2026 |