| K242337 — FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. Apr 17, 2025 |
| K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Benq Materials Corporation Apr 17, 2025 |
| K250889 — EXULT Knee Replacement System | Corentec Co., Ltd. Apr 17, 2025 |
| K242992 — RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) Apr 17, 2025 |
| K250270 — Luja Set | Coloplast Corp. Apr 17, 2025 |
| K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} Apr 17, 2025 |
| K243878 — CLARUS (700) | Carl Zeiss Meditec, Inc. Apr 17, 2025 |
| K243337 — Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. Apr 17, 2025 |
| K243460 — Ultimate rTMS | Brain Ultimate, Inc. Apr 17, 2025 |
| DEN240062 — Minder System | Epi-Minder Pty, Ltd. Apr 17, 2025 |
| K250829 — Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. Apr 17, 2025 |
| K250850 — Nanox.ARC X | Nano-X Imaging , Ltd. Apr 16, 2025 |
| K243513 — DCM (PW-DCM) | Pneumowave, Ltd. Apr 16, 2025 |
| K243853 — Clarius Prostate AI | Clarius Mobile Health Corp. Apr 16, 2025 |
| K242500 — LARALAB | Laralab GmbH Apr 16, 2025 |
| K241733 — HEBE (NP0000763) | Novasonix Technology S.L. Apr 16, 2025 |
| K242806 — Medyssey Navigation System | Medyssey Co, Ltd. Apr 16, 2025 |
| K250809 — Stellar M22 | Lumenis Be, Ltd. Apr 16, 2025 |
| K242647 — MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. Apr 16, 2025 |
| K250833 — SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG Apr 15, 2025 |
| K243055 — Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. Apr 15, 2025 |
| K242786 — TearCare MGX System | Sight Sciences, Inc. Apr 15, 2025 |
| K242773 — Electro Lube NXT | Steris Apr 15, 2025 |
| K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. Apr 15, 2025 |
| K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. Apr 15, 2025 |
| K250327 — OptaBlate Radiofrequency (RF) Generator System | Stryker Instruments Apr 15, 2025 |
| K242932 — Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP Apr 15, 2025 |
| K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation Apr 15, 2025 |
| 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 |