| K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. Apr 21, 2025 |
| K251196 — Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH Apr 21, 2025 |
| K250176 — DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. Apr 21, 2025 |
| K243875 — Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. Apr 21, 2025 |
| K243508 — Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. Apr 21, 2025 |
| K240355 — FROG (Filter Removal of Glass) | Carrtech Corp Apr 18, 2025 |
| K242170 — K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC Apr 18, 2025 |
| K241996 — ULTRA 1040 | Ecoray Co., Ltd. Apr 18, 2025 |
| K250842 — PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation Apr 18, 2025 |
| K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet Apr 18, 2025 |
| K250224 — handLITE (TN19S) | iSMART Developments, Ltd. Apr 18, 2025 |
| K250481 — Extension Feeding Set with ENFit Connectors | SKY Medical, A.S. Apr 18, 2025 |
| K240775 — PeriBeam® Pericardial Membrane | Tamabio Apr 18, 2025 |
| K243734 — Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited Apr 18, 2025 |
| K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC Apr 18, 2025 |
| K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation Apr 18, 2025 |
| K250146 — SofWave System | Sofwave Medical, Ltd. Apr 18, 2025 |
| K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. Apr 18, 2025 |
| K242129 — VitalRhythm | Vitalconnect, Inc. Apr 17, 2025 |
| K243459 — Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. Apr 17, 2025 |
| K250499 — RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. Apr 17, 2025 |
| K243750 — SimpleStitch Suturing System | Envision Endoscopy Apr 17, 2025 |
| 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 |