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| Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary product code |
|---|---|---|---|---|---|
| 2026-07-09 | K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | SU | NEW |
| 2026-07-08 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | OR | ODP |
| 2026-07-06 | K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | RA | LLZ |
| 2026-07-06 | K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | SU | QRL |
| 2026-07-06 | K261909 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | OB | NUC |
| 2026-07-02 | K261129 | OrthoFit | Spident Co., Ltd. | DE | DYH |
| 2026-07-02 | K261847 | iTero Lumina Pro | Align Technology , Ltd. | DE | NTK |
| 2026-07-02 | K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | HO | FRG |
| 2026-07-02 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | GU | FET |
| 2026-06-30 | K261101 | Ceribell Monitor | Ceribell, Inc. | NE | OMC |
| 2026-06-29 | K253969 | ADAS 3D | Adas3D Medical S.L. | RA | QIH |
| 2026-06-29 | K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | RA | QIH |
| 2026-06-25 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | EN | QUH |
| 2026-06-25 | K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | OB | HGX |
| 2026-06-24 | K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | FRO | |
| 2026-06-22 | K261950 | Health Line Tearaway Introducer | Health Line International Corporation | CV | DYB |
| 2026-06-22 | K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | RA | LLZ |
| 2026-06-22 | K261279 | DeltaNEC Interbody System | Nexus Spine | OR | OVE |
| 2026-06-18 | K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. | CV | KRH |
| 2026-06-18 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | HO | FMF |