| K242907 — DELPHI System | CnS Medical Co., Ltd. Jun 6, 2025 |
| K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. Jun 6, 2025 |
| K243639 — Portare System (FA-001) | Grumpy Innovation, Inc. Jun 5, 2025 |
| K242736 — Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Jun 5, 2025 |
| K250616 — Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. Jun 5, 2025 |
| K242744 — Trinity EVO Acetabular Shell | Corin U.S.A. Limited Jun 5, 2025 |
| K251456 — BrightHeart View Classifier | Brightheart Jun 5, 2025 |
| K242750 — Central Station | Nihon Kohden Digital Health Solutions, LLC Jun 5, 2025 |
| K250800 — UroNav 4 | Philips DS North America, LLC Jun 5, 2025 |
| K251084 — zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG Jun 5, 2025 |
| K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts | Medtronic Navigation, Inc. Jun 5, 2025 |
| K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. Jun 5, 2025 |
| K242704 — Synchrony (20-3000) | Synapse Biomedical, Inc. Jun 5, 2025 |
| K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Surgical Instrument Service And Savings, Inc. Jun 5, 2025 |
| K243703 — TechLive | DeepHealth, Inc. Jun 5, 2025 |
| K250467 — Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited Jun 5, 2025 |
| K243667 — Sonic DL | Ge Medical Systems, LLC Jun 5, 2025 |
| K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation Jun 4, 2025 |
| K250749 — PhysCade System | Physcade, Inc. Jun 4, 2025 |
| K250961 — Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. Jun 4, 2025 |
| K243810 — TraumaCad Neo (1.1) | Brainlab , Ltd. Jun 4, 2025 |
| K250804 — ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. Jun 4, 2025 |
| K250118 — Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation Jun 4, 2025 |
| K243368 — Montblanc Plate System | Medifield Medical Co., Ltd. Jun 4, 2025 |
| K250879 — Paradigm System | Proprio, Inc. Jun 4, 2025 |
| K241433 — EVE Synergy (EVE-20M) | Weero Co., Ltd. Jun 4, 2025 |
| K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY Jun 4, 2025 |
| K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. Jun 4, 2025 |
| K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. Jun 4, 2025 |
| K242712 — LubriZenzs | Sk Zen, LLC Jun 4, 2025 |
| K240788 — Ultrasound Stimulator | Jkh Health Co., Ltd. Jun 4, 2025 |
| K243499 — NG-Test® CTX-M MULTI | Ng Biotech Jun 4, 2025 |
| K243843 — Tendon Protect (50242) | Kerecis Limited Jun 4, 2025 |
| K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. Jun 3, 2025 |
| K242897 — Partial Flex | Clemde SA DE CV Jun 3, 2025 |
| K243205 — EVAC | Phasor Health, LLC Jun 3, 2025 |
| K250657 — gi2000 Electrosurgical Generator | Cintron Medical Corporation Jun 3, 2025 |
| K250529 — Globe Introducer (601-01001) | Kardium, Inc. Jun 3, 2025 |
| K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC Jun 3, 2025 |
| K250598 — Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. Jun 3, 2025 |
| K251127 — PENTAX Medical Video Processor (EPK-i8020c) | Pentax Of America, Inc. Jun 3, 2025 |
| K243796 — GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Glove One, LLC Jun 3, 2025 |
| K250001 — Patriot SI Implant System | Spinal Simplicity, LLC Jun 3, 2025 |
| K251035 — DISINTEK PA Test Strips | Serim Research Jun 3, 2025 |
| K243382 — RZ Resectoscope System | Rz Medizintechnik GmbH Jun 3, 2025 |
| K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. Jun 2, 2025 |
| K251335 — Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC Jun 2, 2025 |
| K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. Jun 2, 2025 |
| K250844 — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop | Science & Bio Materials (S.B.M.) Sas Jun 2, 2025 |
| K250410 — GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. Jun 2, 2025 |