| K253693 — Strut Suture; No-Tie Button | Riverpoint Medical, LLC Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254047 — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253624 — INHANCE Reverse Shoulder System | Depuy Ireland UC Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253906 — Xpert Hand | Newclip Technics Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252028 — LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250937 — Venous Return Cannulae | LivaNova USA, Inc. Wed Mar 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260595 — Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253517 — Reselute Tibial Nail | Reselute, Inc. Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260773 — Varios Combi Pro2 | Nakanishi, Inc. Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253953 — IPS e.max Zirconia | Ivoclar Vivadent, Inc. Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254093 — DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252168 — Straumann® BLC Implants - Indication Widening | Institut Straumann AG Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252353 — myray ProXIma X6 | Cefla S.C. Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260765 — Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC Tue Mar 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252888 — NeoSculpt Plus | S&M Medical Co., Ltd. Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260405 — FiberTape Button | Arthrex, Inc. Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253960 — Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253413 — LiverMultiScan (v6.0) | Perspectum, Ltd. Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253668 — Onera SleepMap (SLEEPMAP) | Onera B.V. Sun Mar 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253983 — Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253262 — EmeryGlide (EG18008901) | Nano4imaging GmbH Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253551 — VELYS Hip Navigation | Depuy Ireland UC Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253538 — TeKBrace Knotless Anchor | Theramicro Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253772 — Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260361 — Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253132 — Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260167 — Bunkerhill Contrast AVC | BunkerHill Health Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260013 — CVAC Image Processor | Calyxo, Inc. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252208 — JFord Speculum Sleeve | Ford Medtech, LLC Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260166 — Bunkerhill Contrast CAC | BunkerHill Health Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251818 — BONTREE PLUS | Hudens Bio Co., Ltd. Fri Mar 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260169 — AV Cardiac CT | Philips Medical Systems Nederland B.V. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252538 — CEPHX3D | Orca Dental AI , Ltd. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251788 — Extension tube | Zhuhai DR Medical Instruments Co., Ltd. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253591 — Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253442 — EarliPoint Assessment | Earlitec Diagnostics Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253267 — CORIS System | Nanosonics Limited Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252196 — Arthrex FibuLock Nail System | Arthrex, Inc. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |