| K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. Apr 25, 2025 |
| K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. Apr 25, 2025 |
| K250426 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Apr 25, 2025 |
| K250909 — Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. Apr 25, 2025 |
| K250289 — Intracavitary/Interstitial System | Varian Medical Systems Apr 25, 2025 |
| K242321 — Kosmos | EchoNous, Inc. Apr 25, 2025 |
| K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. Apr 25, 2025 |
| K243721 — Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. Apr 25, 2025 |
| K244026 — PAL 7020 Console | Microaire Surgical Instruments, LLC Apr 25, 2025 |
| K250554 — prodisc® L Instruments | Centinel Spine, LLC Apr 25, 2025 |
| K250892 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Apr 25, 2025 |
| K242469 — RFMagik Lite | Agnes Medical Co., Ltd. Apr 25, 2025 |
| K250153 — Neu Platform | Neuhealth Digital , Ltd. Apr 25, 2025 |
| K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., Apr 25, 2025 |
| K243954 — PeriCross Epicardial Access Kit | Circa Scientific, Inc. Apr 24, 2025 |
| K250206 — Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd Apr 24, 2025 |
| K250002 — Smart Check O2 (MA0236) | Life Spark Medical, LLC Apr 24, 2025 |
| K242214 — Sonu | Sound Health Systems, Inc. Apr 24, 2025 |
| K250183 — CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. Apr 24, 2025 |
| K243239 — Lung AI (LAI001) | Exo, Inc. Apr 24, 2025 |
| K250262 — GO-PEN® | Go-Pen Aps Apr 24, 2025 |
| K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC Apr 24, 2025 |
| 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 |