| K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. Apr 11, 2025 |
| K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP Apr 11, 2025 |
| K242748 — Oncospace | Oncospace, Inc. Apr 11, 2025 |
| K242120 — OTOPLAN | Cascination AG Apr 11, 2025 |
| K243356 — Asiga DentaBASE | Asiga Pty, Ltd. Apr 11, 2025 |
| K242772 — AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. Apr 11, 2025 |
| K250438 — CooperSurgical Milex® Pessaries | CooperSurgical, Inc. Apr 11, 2025 |
| K242600 — Second Opinion Periapical Radiolucency Contours | Pearl, Inc. Apr 11, 2025 |
| K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. Apr 11, 2025 |
| K250371 — cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. Apr 10, 2025 |
| K243145 — syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. Apr 10, 2025 |
| K242045 — Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. Apr 10, 2025 |
| K250177 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Apr 10, 2025 |
| K250754 — cmAngio® (V1.6) | Curemetrix, Inc. Apr 10, 2025 |
| K250058 — NEAT 001 | Brain Electrophysiology Laboratory Company, LLC Apr 10, 2025 |
| K250112 — FitboneTM Trochanteric | Orthofix Srl Apr 10, 2025 |
| K243943 — TriMed® Compression Screws | TriMed, Inc. Apr 10, 2025 |
| K250389 — XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd Apr 10, 2025 |
| K243953 — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. Apr 10, 2025 |
| K250009 — LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited Apr 10, 2025 |
| K243240 — Vitrea CT VScore | Canon Medical Informatics, Inc. Apr 10, 2025 |
| K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. Apr 10, 2025 |
| K242928 — Tesera-k SC System | Kyocera Medical Technologies, Inc. Apr 10, 2025 |
| K250486 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) Apr 10, 2025 |
| K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. Apr 10, 2025 |
| K241589 — Ceribell Seizure Detection Software | Ceribell, Inc. Apr 9, 2025 |
| K250373 — ProLift Expandable Spacer System | Life Spine, Inc. Apr 9, 2025 |
| K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. Apr 9, 2025 |
| K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. Apr 9, 2025 |
| DEN240021 — Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) | Active Protective Technologies, Inc. Apr 9, 2025 |
| K243613 — Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. Apr 9, 2025 |
| K243743 — autoSCORE (V 2.0.0) | Holberg Eeg AS Apr 9, 2025 |
| K242429 — CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Becton Dickinson Inc. (Bd) Apr 9, 2025 |
| K243819 — Luminopia | Luminopia, Inc. Apr 9, 2025 |
| K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. Apr 9, 2025 |
| K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation Apr 9, 2025 |
| K242552 — Horos Mobile | Icat Solutions, Ltd. Apr 8, 2025 |
| K250343 — LuxCreo Clear Aligner System | LuxCreo, Inc. Apr 8, 2025 |
| K243749 — Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. Apr 8, 2025 |
| K250136 — Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. Apr 8, 2025 |
| K250948 — TriMed Fusion Cup System | TriMed, Inc. Apr 8, 2025 |
| K243722 — Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) | Selio Medical Limited Apr 8, 2025 |
| K242295 — BunkerHill BMD | BunkerHill Health Apr 8, 2025 |
| K250708 — NPseal | Guard Medical, Inc. Apr 8, 2025 |
| K243967 — ONE Nitrile Condom | Global Protection Corp. Apr 8, 2025 |
| K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. Apr 8, 2025 |
| K250366 — Electric Wheelchair (LW01301A07) | Anhui Longway Medical Technology Co., Ltd. Apr 8, 2025 |
| K242151 — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | Shenzhen Nuon Medical Equipment Co., Ltd. Apr 8, 2025 |
| K242385 — LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. Apr 7, 2025 |
| K243143 — E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. Apr 7, 2025 |