| K233337 — Freespira Breathing System | Freespira, Inc. Apr 24, 2025 |
| K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC Apr 24, 2025 |
| K242973 — CanMINI Hand and Foot System | Canwell Medical Co., Ltd. Apr 24, 2025 |
| K250116 — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. Apr 24, 2025 |
| K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. Apr 24, 2025 |
| K243714 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Apr 24, 2025 |
| K250198 — Laon Ortho | Laon Medi, Inc. Apr 23, 2025 |
| K243326 — Dynamis Robotic Surgical System | LEM Surgical AG Apr 23, 2025 |
| K250831 — Annalise Enterprise | Annalise-Ai Apr 23, 2025 |
| K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical Apr 23, 2025 |
| K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. Apr 23, 2025 |
| K243697 — MySpine WebPlanner | Medacta International S.A. Apr 23, 2025 |
| K250944 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | Gmp Medicare Sdn. Bhd. Apr 23, 2025 |
| K250155 — Xpert Knee | Newclip Technics Apr 23, 2025 |
| K242232 — Mpact 3D Metal Augments II | Medacta International S.A. Apr 23, 2025 |
| K250228 — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) | Esonic Technology (Wuhan) Co., Ltd. Apr 23, 2025 |
| K243479 — EchoGuide (Version 1) | Sonavex, Inc. Apr 23, 2025 |
| K250869 — Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production Apr 23, 2025 |
| K243621 — Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação Apr 22, 2025 |
| K241931 — OcuMet Beacon (OCUB100) | Ocusciences, Inc. Apr 22, 2025 |
| K242247 — ARIX Femur Nail System | Jeil Medical Corporation Apr 22, 2025 |
| K242542 — Medentika CAD/CAM Abutments | Medentika GmbH Apr 22, 2025 |
| K243944 — Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. Apr 22, 2025 |
| K243343 — BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, Apr 22, 2025 |
| K243386 — Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC Apr 22, 2025 |
| K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. Apr 22, 2025 |
| K243651 — VersaViewer | GE Medical Systems SCS Apr 21, 2025 |
| K243383 — CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. Apr 21, 2025 |
| 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 |