| K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251547 — DESS Dental Smart Solutions | Terrats Medical SL Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252088 — Firebird SI Navigation System | Orthofix US, LLC Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252442 — Kii Structural Balloon Access System | Applied Medical Resources Corp. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250306 — Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252046 — Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250337 — AiORTA - Plan | ViTAA Medical Solutions, Inc. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250325 — BD Alaris Pump Infusion Set | Carefusion (Bd) Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251531 — AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252752 — ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251938 — GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250632 — Arctx Cool Catheter Set | Arctx Medical Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252430 — Freeprint® denture flex | Detax GmbH Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253376 — OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253327 — HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252607 — AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251963 — LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253355 — Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250882 — SANSA HSAT | Huxley Medical Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251772 — Navilas Laser System 577sl (156691) | Od-Os GmbH Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252697 — 3D Laparoscope | Guangdong Optomedic Technologies, Inc. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251985 — LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253345 — JARVIS Diaphyseal Stem Standard | FH Industrie Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253314 — Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252314 — Arthrex SutureTak Suture Anchor | Arthrex, Inc. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253232 — Seguin Annuloplasty Ring | ABBOTT MEDICAL Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252390 — Telescope Guide Extension Catheter | Medtronic, Ireland Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250618 — Medi Lift Essential Eye Mask | Ya-Man, Ltd. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251643 — Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253153 — SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253323 — Protrieve Sheath | Inari Medical Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253242 — LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252351 — UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252547 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252165 — ZIRCONOMER P | Shofu Dental Corporation Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |