| K242996 — EndyMed PRO MAX | Endymed Medical, Ltd. Jun 10, 2025 |
| K250830 — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | Shenzhen Sungrow Led Technology Co., Ltd. Jun 9, 2025 |
| K251500 — MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production Jun 9, 2025 |
| K251093 — Bonvadis® | Oneness Biotech Co., Ltd. Jun 9, 2025 |
| K250465 — CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. Jun 9, 2025 |
| K250746 — Magnetic Surgical System | Levita Magnetics International Corp Jun 7, 2025 |
| K250591 — Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. Jun 6, 2025 |
| K242759 — Geister K-Rex rongeurs | Geister Medizin Technik GmbH Jun 6, 2025 |
| K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris Jun 6, 2025 |
| K251131 — Annex® 2 Adjacent Level System | Spine Wave, Inc. Jun 6, 2025 |
| K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG Jun 6, 2025 |
| K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation Jun 6, 2025 |
| K250109 — TYBR Collagen Gel | Tybr Health Jun 6, 2025 |
| K251525 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC Jun 6, 2025 |
| K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. Jun 6, 2025 |
| K243994 — Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. Jun 6, 2025 |
| K243694 — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Mah Sing Healthcare Sdn. Bhd. Jun 6, 2025 |
| K242431 — Omnia Medical PsiF DNA System | Omnia Medical, LLC Jun 6, 2025 |
| K243456 — ONVOY Acetabular System | Globus Medical, Inc. Jun 6, 2025 |
| K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | Convatec Limited Jun 6, 2025 |
| K251042 — Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technology Co., Ltd. Jun 6, 2025 |
| K251009 — Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. Jun 6, 2025 |
| K243002 — MBA Biotech Implant System | MBA Biotech Co., Ltd. Jun 6, 2025 |
| K251283 — Once-Fil Flow | Mediclus Co., Ltd. Jun 6, 2025 |
| K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.R.L. Jun 6, 2025 |
| K250321 — GCI Sterilization Wrappers | George Courey, Inc. Jun 6, 2025 |
| K250722 — Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. Jun 6, 2025 |
| K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Spa Jun 6, 2025 |
| 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 |