| K244036 — Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. Feb 26, 2025 |
| K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. Feb 26, 2025 |
| K243918 — Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC Feb 26, 2025 |
| K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP Feb 26, 2025 |
| K250346 — BonVie+ | Elute, Inc. Feb 26, 2025 |
| K250281 — DEKA LOTUS | El.En S.P.A. Feb 26, 2025 |
| K241546 — aiCockpit AI Viewer | Fovia, Inc. Feb 26, 2025 |
| K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Feb 26, 2025 |
| K242967 — Loss of Pulse Detection | Fitbit Feb 25, 2025 |
| K242822 — ART-Plan+ (v.3.0.0) | Therapanacea Sas Feb 25, 2025 |
| K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC Feb 25, 2025 |
| K250238 — WasherCap Fixation System | Abanza Tecnomed S.L Feb 25, 2025 |
| K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. Feb 25, 2025 |
| K241601 — EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Feb 25, 2025 |
| K250348 — JLK-AILink | JLK, Inc. Feb 25, 2025 |
| K250223 — BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. Feb 25, 2025 |
| K243446 — 3DXR | GE Medical Systems SCS Feb 25, 2025 |
| K244010 — ExamVue Apex | Jpi Healthcare Co, Ltd. Feb 24, 2025 |
| K241565 — Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. Feb 24, 2025 |
| K243035 — Ulthera® System | Ulthera, Inc. Feb 24, 2025 |
| K241703 — SD Implant System | Arum Dentistry Co., Ltd. Feb 24, 2025 |
| K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. Feb 24, 2025 |
| K243823 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Feb 24, 2025 |
| K242994 — OncoStudio (OS-01) | Oncosoft. Co., Ltd. Feb 24, 2025 |
| K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Feb 24, 2025 |
| K242850 — Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. Feb 21, 2025 |
| K243614 — Sonio Suspect | Sonio Feb 21, 2025 |
| K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. Feb 21, 2025 |
| K243916 — Primus Spinal Fixation System | Spinal Elements, Inc. Feb 21, 2025 |
| K250027 — Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. Feb 21, 2025 |
| K242607 — ScanDiags Ortho L-Spine MR-Q | Scandiags AG Feb 21, 2025 |
| K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV Feb 21, 2025 |
| K243940 — VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. Feb 21, 2025 |
| K243330 — LYMA Laser PRO | Lyma Life , Ltd. Feb 21, 2025 |
| K243431 — Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. Feb 21, 2025 |
| K250218 — Xpert® FII & FV | Cepheid Feb 21, 2025 |
| K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. Feb 21, 2025 |
| K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. Feb 21, 2025 |
| K241983 — Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical Feb 21, 2025 |
| K242898 — Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. Feb 21, 2025 |
| K241563 — Extremity Medical External Fixation System | Extremity Medical, LLC Feb 21, 2025 |
| K241186 — Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. Feb 21, 2025 |
| K243258 — Paradigm System | Proprio, Inc. Feb 21, 2025 |
| K243951 — TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. Feb 21, 2025 |
| K242838 — QuickRad | Aikenist Technologies Pvt, Ltd. Feb 21, 2025 |
| K243278 — Custom Abutments | Institut Straumann AG Feb 21, 2025 |
| K243088 — Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. Feb 21, 2025 |
| K243283 — Alinity h-series System | Abbott Laboratories Feb 20, 2025 |
| K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Edan Instruments, Inc. Feb 20, 2025 |
| K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. Feb 20, 2025 |