| K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC Nov 7, 2024 |
| K212425 — MicroTrend System | Exostat Medical, Inc. Nov 7, 2024 |
| K241719 — NeuroICH | Neurocareai, Inc. Nov 7, 2024 |
| K241468 — Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. Nov 7, 2024 |
| K242379 — LL Implant System | Ossvis Co., Ltd. Nov 7, 2024 |
| K240712 — icobrain aria | Icometrix NV Nov 7, 2024 |
| K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine Nov 7, 2024 |
| K242702 — VioSeal | Spident Co., Ltd. Nov 7, 2024 |
| K242595 — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) | Shenzhen Greatro Electronic Technology Co., Ltd. Nov 7, 2024 |
| K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. Nov 7, 2024 |
| K240831 — MultiCut Solo | Asclepion Laser Technologies GmbH Nov 6, 2024 |
| K242039 — Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co., Ltd. Nov 6, 2024 |
| K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL Nov 6, 2024 |
| K242803 — Compound W Skin Tag Remover | Medtech Products, Inc. Nov 6, 2024 |
| K242719 — ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. Nov 6, 2024 |
| K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) Nov 6, 2024 |
| K240450 — Citrepore | Acuitive Technologies, Inc. Nov 6, 2024 |
| K242261 — Accelx Implant System | Biotech Dental, LLC Nov 6, 2024 |
| K242412 — Agility Symmetric Total Knee System | Medisurge, LLC Nov 6, 2024 |
| K240624 — InfuLife | First Medical Source, LLC Nov 5, 2024 |
| K243106 — CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics , Ltd. Nov 5, 2024 |
| K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | Shenzhen Kentro Medical Electronics Co., Ltd. Nov 5, 2024 |
| K242664 — gentleheel® Adult Incision Device | Gri-Alleset, Inc. Nov 5, 2024 |
| K241312 — TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. Nov 5, 2024 |
| K243015 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. Nov 5, 2024 |
| K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. Nov 5, 2024 |
| K241484 — Atlas Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) Nov 5, 2024 |
| K242345 — Delphi Stimulator | Quantalx Neuroscience Nov 5, 2024 |
| K231287 — POTENZA | Jeisys Medical, Inc. Nov 5, 2024 |
| K242340 — DESS Dental Smart Solutions | Terrats Medical SL Nov 5, 2024 |
| K242947 — FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., Nov 5, 2024 |
| K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | Changsha Anxiang Medical Technology Co., Ltd. Nov 4, 2024 |
| K243061 — SonoStik Guide Wire Introducer | Sonostik, LLC Nov 4, 2024 |
| DEN230083 — Valeda Light Delivery System | Lumithera, Inc. Nov 4, 2024 |
| K240512 — Tixel i (TXLI0001) | Novoxel , Ltd. Nov 4, 2024 |
| K242709 — JLK-PWI | JLK, Inc. Nov 4, 2024 |
| K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever Nov 4, 2024 |
| K242195 — Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. Nov 4, 2024 |
| K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation Nov 4, 2024 |
| K243217 — Legend X Desktop System | Pollogen, Ltd. Nov 1, 2024 |
| K242320 — BD Vacutainer® One Use Holder | Becton, Dickinson And Company Nov 1, 2024 |
| K242076 — VersaCross RF Wire | Baylis Medical Company Nov 1, 2024 |
| K241068 — uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. Nov 1, 2024 |
| K242591 — XERO-alpha | DRTECH Corporation Nov 1, 2024 |
| K242311 — EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria E Comercio Ltda. Nov 1, 2024 |
| K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. Nov 1, 2024 |
| K242620 — Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. Nov 1, 2024 |
| K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | Covidien (Part Of Medtronic) Nov 1, 2024 |
| K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. Nov 1, 2024 |
| K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. Nov 1, 2024 |