| K252427 — Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. Oct 31, 2025 |
| K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation Oct 31, 2025 |
| K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. Oct 31, 2025 |
| K250338 — MSS - Humeral reverse liners extension | Medacta International S.A. Oct 31, 2025 |
| K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda Oct 31, 2025 |
| K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson And Company Oct 31, 2025 |
| DEN240074 — Pulsenmore ES | Pulsenmore, Ltd. Oct 31, 2025 |
| K252060 — GREEN | Phasor Health, LLC Oct 31, 2025 |
| K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC Oct 31, 2025 |
| K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Oct 31, 2025 |
| K252088 — Firebird SI Navigation System | Orthofix US, LLC Oct 31, 2025 |
| K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. Oct 31, 2025 |
| K252442 — Kii Structural Balloon Access System | Applied Medical Resources Corp. Oct 31, 2025 |
| K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. Oct 31, 2025 |
| K250306 — Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. Oct 31, 2025 |
| K252046 — Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. Oct 30, 2025 |
| K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. Oct 30, 2025 |
| K251938 — GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC Oct 30, 2025 |
| K250337 — AiORTA - Plan | ViTAA Medical Solutions, Inc. Oct 30, 2025 |
| K250325 — BD Alaris Pump Infusion Set | Carefusion (Bd) Oct 30, 2025 |
| K251531 — AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC Oct 30, 2025 |
| K252752 — ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. Oct 30, 2025 |
| K252529 — Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation Oct 30, 2025 |
| K250632 — Arctx Cool Catheter Set | Arctx Medical Oct 30, 2025 |
| K252430 — Freeprint® denture flex | Detax GmbH Oct 30, 2025 |
| K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Oct 30, 2025 |
| K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. Oct 30, 2025 |
| K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC Oct 30, 2025 |
| K253376 — OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation Oct 30, 2025 |
| K253327 — HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. Oct 30, 2025 |
| K252607 — AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. Oct 30, 2025 |
| K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. Oct 29, 2025 |
| K251772 — Navilas Laser System 577sl (156691) | Od-Os GmbH Oct 29, 2025 |
| K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. Oct 29, 2025 |
| K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. Oct 29, 2025 |
| K251963 — LOGIQ E10s | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 29, 2025 |
| K253355 — Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC Oct 29, 2025 |
| K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC Oct 29, 2025 |
| K252697 — 3D Laparoscope | Guangdong Optomedic Technologies, Inc. Oct 29, 2025 |
| K250882 — SANSA HSAT | Huxley Medical Oct 29, 2025 |
| K251985 — LOGIQ E10 | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 29, 2025 |
| K253345 — JARVIS Diaphyseal Stem Standard | FH Industrie Oct 29, 2025 |
| K253314 — Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. Oct 29, 2025 |
| K252314 — Arthrex SutureTak Suture Anchor | Arthrex, Inc. Oct 29, 2025 |
| K253232 — Seguin Annuloplasty Ring | ABBOTT MEDICAL Oct 29, 2025 |
| K252390 — Telescope Guide Extension Catheter | Medtronic, Ireland Oct 29, 2025 |
| K250618 — Medi Lift Essential Eye Mask | Ya-Man, Ltd. Oct 29, 2025 |
| K251643 — Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) Oct 29, 2025 |
| K253153 — SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC Oct 29, 2025 |
| K253323 — Protrieve Sheath | Inari Medical Oct 29, 2025 |