510(k) Clearances
| K260369 — Dynamis Robotic Surgical System | LEM Surgical AG Sat Jun 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252982 — CONDUIT ZERO-P VA Secured Spacer System | Avalign Technologies, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253131 — Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252066 — inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | Vincent Healthcare Products Limited Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253187 — SteriBest® Sterilization Tray System | Mastel Surgical Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253776 — Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253812 — Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261665 — CORUS Navigation System-GN | Providence Medical Technology, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253050 — RadOncAI | Informai Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254169 — SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260946 — LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253058 — Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251559 — InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252839 — ZywieZ3 Sensor & Adhesive | Zywie, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253678 — MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261701 — Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251232 — MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253116 — 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253824 — Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250025 — Syncron-E | Autonomous Healthcare, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260178 — Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250806 — Dental Implant System | A.B. Dental Devices , Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260190 — ARTHUR | ROPCA ApS Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260820 — VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261246 — SRGC-06 | GC America, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261099 — Blood Volume Analyzer (200) | Daxor Corporation Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253521 — ECMT-100 WMD | Ecm Therapeutics, Inc. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261713 — Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253126 — Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261651 — Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253055 — Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Nordic Kinetics AB Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253155 — Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260006 — INOSS System | Inosys, Inc. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253634 — CoolSeal Generator® (CSL-200-90) | Hologic, Inc. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261631 — Amplatzer TorqVue Exchange System | Abbott Medical Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253333 — Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261544 — Hydro Irrigation System | Stryker Instruments Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260916 — FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261570 — PICOSURE WORKSTATION | Cynosure, LLC Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261638 — Bonvadis® | Oneness Biotech Co., Ltd. Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
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