| K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. Jul 2, 2025 |
| K251285 — Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd. Jul 2, 2025 |
| K243701 — AuroLase® System | Nanospectra Biosciences, Inc. Jul 2, 2025 |
| K243399 — Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC Jul 2, 2025 |
| K250779 — CS-Pro MED | Curative Sound Therapeutics Jul 2, 2025 |
| K250415 — G0 Blood Pressure Monitoring System (G0) | Aktiia SA Jul 2, 2025 |
| K251720 — OsteoFlo HydroFiber | SurGenTec, LLC Jul 2, 2025 |
| K250587 — Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. Jul 2, 2025 |
| K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP Jul 2, 2025 |
| K250524 — Mendaera Guidance System | Mendaera, Inc. Jul 2, 2025 |
| K251746 — Pure Impact | Sofwave Medical, Ltd. Jul 2, 2025 |
| K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. Jul 2, 2025 |
| K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB Jul 2, 2025 |
| K251049 — SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. Jul 2, 2025 |
| K251241 — EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. Jul 2, 2025 |
| K250684 — OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant Jul 2, 2025 |
| K250848 — Identity Shoulder System | Zimmer, Inc. Jul 2, 2025 |
| K251031 — Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. Jul 2, 2025 |
| K250016 — droplet® personal lancets | Htl-Strefa S.A Jul 1, 2025 |
| K243690 — SonoMSK | PAJUNK GmbH Medizintechnologie Jul 1, 2025 |
| K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. Jul 1, 2025 |
| K243485 — Alinity m CMV | Abbott Molecular, Inc. Jul 1, 2025 |
| K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health Jul 1, 2025 |
| K251453 — Arthrex iBalance Partial Knee System | Arthrex, Inc. Jul 1, 2025 |
| K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | Convatec Jul 1, 2025 |
| K251032 — MiniMed 780G insulin pump | Medtronic Minimed, Inc. Jul 1, 2025 |
| K250221 — StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. Jul 1, 2025 |
| K251719 — Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. Jul 1, 2025 |
| K250096 — Felix NeuroAI System | Fasikl Incorporated Jul 1, 2025 |
| K251933 — SnugFit ASA Extension | Medacta International S.A. Jul 1, 2025 |
| K250204 — Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. Jul 1, 2025 |
| K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific Jun 30, 2025 |
| K250670 — EchoConfidence (USA) | Mycardium AI Limited Jun 30, 2025 |
| K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. Jun 30, 2025 |
| K250484 — PIUR tUS inside | Piur Imaging GmbH Jun 30, 2025 |
| K243647 — Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation Jun 30, 2025 |
| K250022 — HeroTracker Sense | Voluntis Jun 30, 2025 |
| K251000 — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Jun 30, 2025 |
| K251088 — Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. Jun 30, 2025 |
| K250972 — Primum Hydrophilic Guiding Catheter | Pendracare Jun 29, 2025 |
| K250585 — LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. Jun 27, 2025 |
| K243130 — Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., Jun 27, 2025 |
| K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. Jun 27, 2025 |
| K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4You AG Jun 27, 2025 |
| K251210 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Jun 27, 2025 |
| K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. Jun 27, 2025 |
| K243682 — SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie Jun 27, 2025 |
| K251431 — FIX-C PEEK ACIF SA System | Jeil Medical Corporation Jun 27, 2025 |
| K250648 — Philips iCT CT system | Philips Medical Systems Nederland B.V. Jun 27, 2025 |
| K243077 — Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Jun 27, 2025 |