| K254123 — Ecomed Disposable Administration Sets | Ecomed Solutions, LLC Sep 11, 2026 |
| K262025 — Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis Sep 11, 2026 |
| K261837 — FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. Sep 11, 2026 |
| K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. Sep 11, 2026 |
| K254174 — Surgical Power System | Guizhou Zirui Technology Co., Ltd. Sep 11, 2026 |
| K260410 — Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. Sep 11, 2026 |
| K254185 — Potenza Prime | Jeisys Medical Incorporated Sep 11, 2026 |
| K254051 — Extroducer Infusion Catheter System | SmartWise Sweden AB Sep 11, 2026 |
| K262007 — PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. Sep 11, 2026 |
| K253063 — Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation Sep 11, 2026 |
| K261338 — RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. Sep 11, 2026 |
| K260063 — GSPE Spacer | The General Hospital Corporation, D/B/A Massachusetts Sep 11, 2026 |
| K261255 — KOWA FM-600 | Kowa Company, Ltd. Chofu Factory Sep 11, 2026 |
| K260115 — DRIM-Nail System | 41Medical AG Sep 11, 2026 |
| K262763 — iLet Dosing Decision Software | Beta Bionics, Inc. Sep 11, 2026 |
| K254009 — Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. Sep 10, 2026 |
| K254111 — Irrigation/Urology Sets | B.Braun Medical, Inc. Sep 10, 2026 |
| K261929 — Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. Sep 10, 2026 |
| K260879 — 4DM | INVIA, LLC Sep 10, 2026 |
| K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. Sep 10, 2026 |
| K260110 — danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH Sep 10, 2026 |
| K261696 — ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. Sep 10, 2026 |
| K262293 — EVOLUTION MPX Total Knee System | Suzhou Microport Orthorecon Co., Ltd. Sep 10, 2026 |
| K254246 — LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. Sep 10, 2026 |
| K262202 — Cerasmart Forte | GC America, Inc. Sep 10, 2026 |
| K261795 — Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. Sep 10, 2026 |
| K254074 — TruPress | Procerus Enterprises Sep 10, 2026 |
| K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. Sep 10, 2026 |
| K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. Sep 10, 2026 |
| K261409 — BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. Sep 10, 2026 |
| K261562 — Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. Sep 10, 2026 |
| K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. Sep 9, 2026 |
| K261470 — QF10 | E.A.M Benelux B.V Sep 9, 2026 |
| K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. Sep 9, 2026 |
| K252486 — ChestView US (1.1) | Gleamer Sep 9, 2026 |
| K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. Sep 9, 2026 |
| K260652 — ColActive Plus | Covalon Technologies, Ltd. Sep 9, 2026 |
| K260997 — SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. Sep 9, 2026 |
| K251417 — ReVISION 2 | Argus Cognitive, Inc. Sep 9, 2026 |
| K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation Sep 8, 2026 |
| K261987 — Reusable SmartPeg | Osstell AB Sep 8, 2026 |
| K261462 — LANDMARK Total Knee System | Smith & Nephew, Inc. Sep 8, 2026 |
| K260062 — MODI System | DreaMed Diabetes, Ltd. Sep 8, 2026 |
| K262173 — N22 Offset Humeral Head | Shoulder Innovations, Inc. Sep 8, 2026 |
| K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. Sep 8, 2026 |
| K260053 — Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. Sep 8, 2026 |
| K261956 — Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. Sep 8, 2026 |
| K253988 — LiteSet Trays | Nobel Biocare AB Sep 8, 2026 |
| K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. Sep 8, 2026 |
| K261715 — Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. Sep 8, 2026 |