| K242440 — Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. Nov 14, 2024 |
| K242436 — Proximal Humerus Fixation System | Skeletal Dynamics, Inc. Nov 14, 2024 |
| K242342 — Fetal EchoScan | Brightheart Nov 14, 2024 |
| K241339 — Besmed Bacterial Filter and HMEF | Besmed Health Business Corp Nov 14, 2024 |
| K241397 — Hinscope | Hinlab Sas Nov 14, 2024 |
| K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | Huizhou Foryou Medical Devices Co., Ltd. Nov 13, 2024 |
| K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. Nov 13, 2024 |
| K211498 — Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. Nov 13, 2024 |
| K242407 — Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. Nov 13, 2024 |
| K243273 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Nov 13, 2024 |
| K241135 — RESPOND(R) Ventilator | Corvent Medical, Inc. Nov 13, 2024 |
| K242764 — MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. Nov 13, 2024 |
| DEN240023 — SmartFlow Neuro Cannula | ClearPoint Neuro, Inc. Nov 13, 2024 |
| K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed Nov 12, 2024 |
| K242791 — Electric wheelchair (KR-8807) | Zhejiang Kairui Medical Device Co., Ltd. Nov 12, 2024 |
| K242430 — Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) | Soul Mobility Nov 12, 2024 |
| K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Coloplast Corp. Nov 12, 2024 |
| K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. Nov 12, 2024 |
| DEN230085 — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Steris Nov 12, 2024 |
| K230915 — AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Vyaire Medical, Inc. Nov 12, 2024 |
| K242420 — pNOVUS 21 Microcatheter | Phenox, Ltd. Nov 12, 2024 |
| K242502 — Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada Supermax Medical Nov 12, 2024 |
| K241981 — Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company Nov 12, 2024 |
| K240771 — PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited Nov 12, 2024 |
| K242018 — UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. Nov 12, 2024 |
| K241575 — Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC Nov 11, 2024 |
| K243233 — esolution® Esophageal Retractor | S4 Medical Corp. Nov 9, 2024 |
| K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. Nov 8, 2024 |
| K243231 — Trigon PEEK HA Wedges | Nvision Biomedical Technologies Nov 8, 2024 |
| K242231 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 8, 2024 |
| K241342 — Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. Nov 8, 2024 |
| K240417 — ProFound Detection (V4.0) | Icad, Inc. Nov 8, 2024 |
| K242286 — Superflow Prime Treatment System (ASP-1M) | Guangzhou Aimira Innovation Technology Co, Ltd. Nov 8, 2024 |
| K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG Nov 8, 2024 |
| K240510 — Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. Nov 8, 2024 |
| K241099 — Plasonic (Plasonic) | Hironic Co., Ltd. Nov 8, 2024 |
| K243004 — Xpine Spinal Fixation System | Jeil Medical Corporation Nov 8, 2024 |
| K241802 — Device 300397 Putty | Geistlich Pharma AG Nov 8, 2024 |
| K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation Nov 8, 2024 |
| K240794 — Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. Nov 8, 2024 |
| K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. Nov 8, 2024 |
| K242382 — décoLITE LED Device | iSMART Developments, Ltd. Nov 8, 2024 |
| K242756 — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | Pulnovo Medical (Wuxi) Co., Ltd. Nov 8, 2024 |
| K241364 — Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB Nov 8, 2024 |
| K242734 — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab Nov 7, 2024 |
| K240429 — Trilogy Tissue Marker | Inrad, Inc. Nov 7, 2024 |
| K240415 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Nov 7, 2024 |
| K242373 — Mako Shoulder Application (1.0) | Mako Surgical Corp. Nov 7, 2024 |
| K241346 — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. Nov 7, 2024 |
| K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix Nov 7, 2024 |