| K260432 — Ruby Intravascular Catheter | Venocare, Inc. Sep 2, 2026 |
| K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical Sep 2, 2026 |
| K254198 — Trexo Theo | Trexo Robotics, Inc. Sep 2, 2026 |
| K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. Sep 1, 2026 |
| K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. Sep 1, 2026 |
| K260884 — UNIDRIVE Select System | Karl Storz SE & CO. KG Sep 1, 2026 |
| K260656 — Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy Sep 1, 2026 |
| K262783 — RadiForce MX247W | Eizo Corporation Sep 1, 2026 |
| K261811 — PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. Sep 1, 2026 |
| K253961 — SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. Sep 1, 2026 |
| K262451 — Arthrex DynaNite Staples | Arthrex, Inc. Sep 1, 2026 |
| K260613 — AMI Plasma Cartridge, AMI | Sequitur Health Corp. Sep 1, 2026 |
| K262269 — CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. Sep 1, 2026 |
| K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. Aug 31, 2026 |
| K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC Aug 31, 2026 |
| K260488 — MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. Aug 31, 2026 |
| K261718 — EZFluence (RADEZ V2) | Radformation, Inc. Aug 31, 2026 |
| K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. Aug 31, 2026 |
| K262788 — Nova HD+ | Aura Wellness, LLC Aug 31, 2026 |
| K262658 — Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. Aug 31, 2026 |
| K254217 — Aerloom | Evolym, LLC Aug 31, 2026 |
| K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. Aug 31, 2026 |
| K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. Aug 31, 2026 |
| K262013 — Kiba CTO Crossing Catheter | Reflow Medical, Inc. Aug 28, 2026 |
| K261830 — FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi Aug 28, 2026 |
| K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy Aug 28, 2026 |
| K260517 — Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. Aug 28, 2026 |
| K261378 — Rayvolve AZchest | AZmed Aug 28, 2026 |
| K261176 — Zoom 4S Catheter | Imperative Care, Inc. Aug 28, 2026 |
| K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Aug 28, 2026 |
| K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. Aug 28, 2026 |
| K260203 — Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. Aug 28, 2026 |
| K260617 — Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. Aug 28, 2026 |
| K253630 — Mpact 3D Metal Foam | Medacta International S.A. Aug 28, 2026 |
| K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. Aug 28, 2026 |
| K253954 — X-Guide Surgical Navigation System | X-Nav Technologies, LLC Aug 28, 2026 |
| K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. Aug 28, 2026 |
| K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. Aug 28, 2026 |
| K262722 — Primal K-Wire (P99-193-1410) | Paragon 28, Inc. Aug 28, 2026 |
| K261360 — EasyCare Tx 2 | Resmed Corp Aug 27, 2026 |
| K260870 — Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company Aug 27, 2026 |
| K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care Aug 27, 2026 |
| K262744 — GenesisX RMN | Stereotaxis, Inc. Aug 27, 2026 |
| K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials Aug 27, 2026 |
| K262654 — Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd Aug 27, 2026 |
| K260751 — 35 Helix Guidewire | Piraeus Medical, Inc. Aug 27, 2026 |
| K261802 — Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. Aug 27, 2026 |
| K262268 — Optiflow Oxygen Kit (AA484J) | Fisher And Paykel Healthcare Limited Aug 27, 2026 |
| K262677 — Iconix Knotless T | Riverpoint Medical Aug 27, 2026 |
| K260481 — GC85A | Samsung Electronics Co., Ltd. Aug 27, 2026 |