| K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250264 — SugarBug (1.x) | Bench7, Inc. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250423 — mb-FIX Cranial Stabilization Systems | Medical Bees GmbH Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252515 — Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252525 — AIO Breathe | Aiomega, LLC Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250815 — Hubly Drill (H100) | Hubly, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253265 — BriefCase-Triage | Aidoc Medical , Ltd. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251555 — Ultra Compression Screw System | Pace Surgical Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252418 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253074 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252845 — Venus Nova (FP-2001) | Venus Concept, Inc. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252133 — Adaptix Ortho350 | Adaptix Limited Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252514 — EVAC-MRI | Phasor Health, LLC Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250375 — Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250376 — ViVY | Viatherm Therapeutics, LLC Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252677 — Polyshield Safety IV Catheters | Poly Medicure Limited Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250599 — ExcelsiusGPS Instruments | Globus Medical, Inc. Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252664 — GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251303 — Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251709 — MedCAD® AccuStride System | Medcad Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251410 — VXvue | Vieworks Co., Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250853 — Merit Syringe | Merit Medical Systems, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252964 — PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250576 — Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250241 — Cios Select | Siemens Medical Solutions USA, Inc. Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253448 — Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252484 — cobas HCV | Roche Molecular Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250330 — 3mensio Workstation | Pie Medical Imaging BV Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251626 — Midmark Dental Delivery System | Midmark Corporation Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252458 — Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252671 — Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252481 — cobas CMV | Roche Molecular Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252698 — NightGuard Aire Max | Nightguard Express, LLC Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250392 — ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240074 — Pulsenmore ES | Pulsenmore, Ltd. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252427 — Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252060 — GREEN | Phasor Health, LLC Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250338 — MSS - Humeral reverse liners extension | Medacta International S.A. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |