| K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Apr 15, 2025 |
| K250212 — LapBox Power Tissue Containment System | Ark Surgical Apr 15, 2025 |
| K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. Apr 14, 2025 |
| K250301 — Merge Universal Viewer (MUV) | Merge Healthcare Incorporated Apr 14, 2025 |
| K250402 — AVAVA Skin Treatment System | AVAVA, Inc. Apr 14, 2025 |
| K250823 — Any-Com Flow | Mediclus Co., Ltd. Apr 14, 2025 |
| K250094 — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | Neuralynx, Inc. Apr 14, 2025 |
| K243852 — Elfor-L | Elfi-Tech , Ltd. Apr 14, 2025 |
| DEN240064 — CT-132 | Click Therapeutics, Inc. Apr 11, 2025 |
| K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. Apr 11, 2025 |
| K243898 — Chlorine Sentinel II | Nelson Environmental Technologies, Inc. Apr 11, 2025 |
| K250416 — GBrain MRI | Galileo Cds, Inc. Apr 11, 2025 |
| K250081 — Atlantis® Abutments in Titanium | Dentsply Sirona Apr 11, 2025 |
| K243044 — Alma Harmony | Alma Lasers, Inc. Apr 11, 2025 |
| K243921 — LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. Apr 11, 2025 |
| K250748 — KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH Apr 11, 2025 |
| K243710 — Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. Apr 11, 2025 |
| K243558 — Canvas Dx | Cognoa, Inc. Apr 11, 2025 |
| K242646 — Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. Apr 11, 2025 |
| K250811 — Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. Apr 11, 2025 |
| K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation Apr 11, 2025 |
| K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. Apr 11, 2025 |
| 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 |