| Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (K251381) | Ceribell, Inc. | 2025-10-31 |
| Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (K252412) | Applied Medical Resources Corporation | 2025-10-31 |
| Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777) | Maxx Orthopedics, Inc. | 2025-10-31 |
| MSS - Humeral reverse liners extension (K250338) | Medacta International S.A. | 2025-10-31 |
| Diode Laser Hair Removal Machine (GLD01) (K252427) | Sanhe Meditech Co., Ltd. | 2025-10-31 |
| Kii Structural Balloon Access System (K252442) | Applied Medical Resources Corp. | 2025-10-31 |
| 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); (K253501) | Vigodent Indústria E Comercio Ltda | 2025-10-31 |
| Firebird SI Navigation System (K252088) | Orthofix US, LLC | 2025-10-31 |
| Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (K252074) | Canon Medical Systems Corporation | 2025-10-31 |
| DESS Dental Smart Solutions (K251547) | Terrats Medical SL | 2025-10-31 |
| 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 (K250358) | Becton, Dickinson and Company | 2025-10-31 |
| GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (K251041) | Actuated Medical, Inc. | 2025-10-31 |
| Pulsenmore ES (DEN240074) | Pulsenmore, Ltd. | 2025-10-31 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K252160) | Persyst Development, LLC | 2025-10-31 |
| Chex-All Sterilization Pouches and Tubes (K250306) | Propper Manufacturing Co., Inc. | 2025-10-31 |
| Zoom System (Zoom 4S Catheter) (K252046) | Imperative Care, Inc. | 2025-10-30 |
| BD Alaris Pump Infusion Set (K250325) | Carefusion (Bd) | 2025-10-30 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Niti-S Esophageal Stent; Esophageal TTS Stent (K243619) | Taewoong Medical Co., Ltd. | 2025-10-30 |
| AiORTA - Plan (K250337) | ViTAA Medical Solutions, Inc. | 2025-10-30 |
| Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) | Tornier, Inc. | 2025-10-30 |
| Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) (K252529) | Boston Scientific Corporation | 2025-10-30 |
| Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (K252387) | Diasorin Molecular, LLC | 2025-10-30 |
| HANAROSTENT Esophagus Upper (CCC) (K253327) | M.I.Tech Co., Ltd. | 2025-10-30 |
| GEN5 and GEN5+ Dental Implant System (K251938) | Paragon Implant Mfg., LLC | 2025-10-30 |
| Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (K252414) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-30 |
| AllTest Urinary Tract Infection Test (K252607) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| Arctx Cool Catheter Set (K250632) | Arctx Medical | 2025-10-30 |
| ellacor System with Micro-Coring Technology (K252752) | Cytrellis Biosystems, Inc. | 2025-10-30 |
| Freeprint® denture flex (K252430) | Detax GmbH | 2025-10-30 |
| AIR COMPRESSION BOOTS 1018195,1018196 (K251531) | Merchsource, LLC | 2025-10-30 |
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| Arthrex SutureTak Suture Anchor (K252314) | Arthrex, Inc. | 2025-10-29 |
| Freedom Infinia™ Total Knee System (K253314) | Maxx Orthopedics, Inc. | 2025-10-29 |
| AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416) | Smith & Nephew, Inc. | 2025-10-29 |
| Synchfix EVT (K251643) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| Telescope Guide Extension Catheter (K252390) | Medtronic, Ireland | 2025-10-29 |
| Meduloc Intramedullary Fracture Fixation (IFF) System (K250316) | Meduloc, LLC | 2025-10-29 |
| LOGIQ E10s (K251963) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| SANSA HSAT (K250882) | Huxley Medical | 2025-10-29 |
| Protrieve Sheath (K253323) | Inari Medical | 2025-10-29 |
| 3D Laparoscope (K252697) | Guangdong Optomedic Technologies, Inc. | 2025-10-29 |
| LCD Monitor (C1216W, C822W, C821W) (K253242) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-10-29 |
| JARVIS Diaphyseal Stem Standard (K253345) | FH Industrie | 2025-10-29 |
| Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (K253283) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-10-29 |
| Navilas Laser System 577sl (156691) (K251772) | Od-Os GmbH | 2025-10-29 |
| SER Pen Carain MicroSystem (MP1209SP) (K253153) | Su-Ko Technologies, LLC | 2025-10-29 |
| Difiney Advanced Anti Snoring Device 4.0 (K253355) | Fissiontech, LLC | 2025-10-29 |
| Seguin Annuloplasty Ring (K253232) | ABBOTT MEDICAL | 2025-10-29 |
| Medi Lift Essential Eye Mask (K250618) | Ya-Man, Ltd. | 2025-10-29 |
| LOGIQ E10 (K251985) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-10-29 |
| Yomi S Robotic System (K252376) | Neocis, Inc. | 2025-10-28 |
| ZIRCONOMER P (K252165) | Shofu Dental Corporation | 2025-10-28 |
| Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (K253399) | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025-10-28 |
| Fine Osteotomy™ (K253300) | Bodycad Laboratories, Inc. | 2025-10-28 |
| PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (K250275) | Baylis Medical Technologies, Inc. | 2025-10-28 |
| UniSpace® TPLIF Cage (K252351) | Cg Medtech Co., Ltd. | 2025-10-28 |
| 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 (K251466) | Wellell, Inc. | 2025-10-28 |
| TheraSphere 360™ Y-90 Management Platform (K252547) | Boston Scientific Corporation | 2025-10-28 |
| Navigated Instruments (K252742) | Tyber Medical, LLC | 2025-10-28 |
| Patriot Duo (K251824) | Patriot Laser, LLC | 2025-10-27 |
| Blood Pressure Monitor (B73, BE23T) (K251331) | Shenzhen Jamr Technology Co., Ltd. | 2025-10-27 |
| Electric Breast Pump (HL-3058, F5112) (K252629) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 |
| TECHFIT Patient-Specific Cranial System (K250297) | Techfit Digital Surgery, Inc. | 2025-10-27 |
| Disposable Vinyl Examination Gloves (K252467) | Viet Phu Trade and Import Export Co., Ltd. | 2025-10-27 |
| VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (K252053) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 2025-10-27 |
| OsteoCentric Navigated Instruments System (K250520) | Osteocentric Technologies, Inc. | 2025-10-27 |
| Electric Breast Pump (HL-3060, F5113) (K252630) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 |
| cvi42 Coronary Plaque Software Application (K251027) | Circle Cardiovascular Imaging, Inc. | 2025-10-27 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K251875) | Affinity Biosensors, LLC | 2025-10-27 |
| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| Vesalio Peripheral System (K251312) | Vesalio, Inc. | 2025-10-24 |
| AngioVac Cannula (K253106) | AngioDynamics, Inc. | 2025-10-24 |
| LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645) | Philips Medical Systems Nederland B.V. | 2025-10-24 |
| Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (K252646) | Olympus Medical Systems Corp. | 2025-10-24 |
| AccuCheck (K250696) | Manteia Technologies Co., Ltd. | 2025-10-24 |
| Atalante X (K250904) | Wandercraft SAS | 2025-10-24 |
| Mobile X-ray unit (!M1) (K251710) | Solutions For Tomorrow AB | 2025-10-24 |
| Syngo Carbon Clinicals (VA41) (K251059) | Siemens Healthineers AG | 2025-10-24 |
| Arctic Sun Temperature Management System (Model 5000) (K251974) | Medivance, Inc. | 2025-10-24 |
| Fule Spinal Fixation System (K252730) | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 |
| Cryon-X Cold Compression (K253150) | Jkh Health Co., Ltd. | 2025-10-24 |
| CoroFlow Cardiovascular System (K252238) | Coroventis Research AB | 2025-10-24 |
| Cocoon Solo (DX-7020s) (K250687) | Dexcowin Global, Inc. | 2025-10-24 |
| Hushd Pro Z-Link (K251784) | Good Sleep CO Pte , Ltd. | 2025-10-24 |
| Medline Bag Decanter (K250345) | Medline Industries, LP | 2025-10-24 |
| VersaD Delivery Catheter (K251372) | Unity Medical, Inc. | 2025-10-24 |
| Expandable Titanium PLIF/TLIF System (K253377) | Spectrum Spine, Inc. | 2025-10-24 |
| Glucose2 (K252357) | Abbott Ireland | 2025-10-24 |
| Azurion R3.1 (K251827) | Philips Medical Systems B.V. | 2025-10-24 |
| Triathlon® Total Knee System - Triathlon® Gold Femoral Components (K252044) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| Parietene™ Flat Sheet Mesh (K253125) | Medtronic - Sofradim Production | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (K250861) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| DESS® Dental Smart Solutions (K252384) | Terrats Medical SL | 2025-10-23 |
| MultiPulse TFL (K253100) | Asclepion Laser Technologies GmbH | 2025-10-23 |
| Silatrix Oral Gel (K252425) | Sa3, LLC | 2025-10-23 |
| 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (K252732) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-10-23 |
| UV5000W Handle (K253226) | Uroviu Corporation | 2025-10-23 |