| Fenom Flo™ FeNO Monitoring System (K251674) | Mgc Diagnostics Corporation | 2025-11-26 |
| Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (K252405) | Surgical Instrument Service and Savings, Inc. | 2025-11-26 |
| 0.014” Willow Guidewire (K253168) | Arbor Endovascular, LLC | 2025-11-26 |
| Tru Kidney Health Test Panel; Tru Analyzer (K251058) | Truvian Health | 2025-11-26 |
| Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (K242976) | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 |
| CEREC Tessera Abutment System (K252248) | Dentsply Sirona | 2025-11-26 |
| MuReva OM™ (DEN240077) | Mureva Phototherapy, Inc. | 2025-11-26 |
| K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (K252355) | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 |
| Vanquish Water Vapor Ablation Device (K252388) | Francis Medical, Inc. | 2025-11-26 |
| 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (K253310) | Esaote, S.p.A. | 2025-11-25 |
| Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (K252889) | Olympus Medical Systems Corporation | 2025-11-25 |
| enCore Night Guard (K252004) | Encore Guards | 2025-11-25 |
| FEops HEARTguide Simulation Application (K250635) | Feops NV | 2025-11-25 |
| NX01 (NX01) (K251550) | Naox Technologies Sas | 2025-11-25 |
| BELLUS-Q (K253344) | Speclipse, Inc. | 2025-11-25 |
| Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (K252253) | Geistlich Pharma AG | 2025-11-25 |
| Scaida BrainCT-ICH (v1.0) (K250694) | Mlhealth 360 | 2025-11-25 |
| HALO AP Dx (K252762) | Indica Labs, LLC | 2025-11-25 |
| Hushd Avera (K252161) | Good Sleep CO Pte , Ltd. | 2025-11-25 |
| Spectra Platinum (K251932) | Uzinmedicare Co., Ltd. | 2025-11-25 |
| Akura Thrombectomy System (K251070) | Akura Medical | 2025-11-25 |
| LeafPure-Echo (LM-LPNdA) (K253219) | Shenzhen Leaflife Technology Co., Ltd. | 2025-11-25 |
| IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) (K253304) | Dongguan Lide Electric Appliance Co., Ltd. | 2025-11-25 |
| LuxCreo Flexible Partial Denture Resin (K253365) | LuxCreo, Inc. | 2025-11-25 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| Eva Scalp Cooling System (K252289) | Stemtech Medical Devices Private Limited | 2025-11-25 |
| PennPET Explorer Positron Emission Tomograph (K251401) | Trustees of the University of Pennsylvania | 2025-11-25 |
| RCT700 (K251798) | Ray Co., Ltd. | 2025-11-25 |
| ZSFab Lumbar Interbody System (K252610) | Zsfab, Inc. | 2025-11-25 |
| a2z-Unified-Triage (K252366) | A2z Radiology Ai, Inc. | 2025-11-24 |
| Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) (K252771) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 |
| F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (K252704) | F Care Systems USA, LLC | 2025-11-24 |
| Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (K242503) | Eurosets S.R.L | 2025-11-24 |
| The BAG manual resuscitator and accessories (K251631) | Laerdal Medical AS | 2025-11-24 |
| BCM2-Body Composition Monitor (K250634) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| NeVa PV Thrombectomy Device (K253407) | Vesalio, Inc. | 2025-11-24 |
| AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509) | AngioDynamics, Inc. | 2025-11-24 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K252328) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-11-24 |
| Dakota LP System (K250769) | Precision Spine, Inc. | 2025-11-24 |
| Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (K252688) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025-11-24 |
| Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) (K252787) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-24 |
| KARL STORZ Cholangiography Set (K250927) | Karl Storz SE & CO. KG | 2025-11-22 |
| Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (K251205) | Dentsply Sirona | 2025-11-21 |
| Oxygen Concentrator (J5A) (K251607) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 |
| FluoroDose Varnish (K250714) | Centrix, Inc. | 2025-11-21 |
| BEE HA (K250560) | NGMedical GmbH | 2025-11-21 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K251849) | Staclear, Inc. | 2025-11-21 |
| TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) (K253681) | Graphy, Inc. | 2025-11-21 |
| Nelli (Version 7.11) (K251506) | Neuro Event Labs OY | 2025-11-21 |
| EffortMed PEEK Cages & Corpectomy Cages (K252686) | Effortmed, LLC | 2025-11-21 |
| Pen Injector Needle 32.5 (K250700) | Terumo Corporation | 2025-11-21 |
| Articulator Arthroscopic Bur (K252666) | Joint Preservation Innovations, LLC | 2025-11-21 |
| Ceribell Infant Seizure Detection Software (K252070) | Ceribell, Inc. | 2025-11-21 |
| Manual Wheelchair (HM305-Air1, HM305-Air2) (K252687) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 |
| Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (K251856) | Everyway Medical Instruments Co.,Ltd | 2025-11-21 |
| LEGACY (K252696) | Phasor Health, LLC | 2025-11-21 |
| Powered Mobility Scooter (PMS105, GUT177, GCAT047) (K252590) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 |
| CardioVision (K251293) | Icardio.Ai | 2025-11-21 |
| Archy Dental Imaging (K251880) | Archy Dental, Inc. | 2025-11-21 |
| Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (K250586) | Deroyal Industries, Inc. | 2025-11-21 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K251822) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 |
| PlanOne 1 (K250963) | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) (K251904) | Remington Medical, Inc. | 2025-11-20 |
| syngo.MR Applications (VB80) (K253495) | Siemens Healthineers AG | 2025-11-20 |
| Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) (K253007) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-11-20 |
| CORUS-LX Implant (K253190) | Providence Medical Technology, Inc. | 2025-11-20 |
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| TaperSet™ Hip System (K252846) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| OptumSI Implant System (K251365) | Si Solutions, LLC | 2025-11-20 |
| Nuvis® Wireless HD Camera System (Nuvis-2K) (K242606) | Integrated Endoscopy, Inc. | 2025-11-20 |
| UltraPrint-Dental Denture UV (K253324) | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| CuRAS hybrid (K253123) | Classys, Inc. | 2025-11-20 |
| Disposable Polymer Ligation Clips (K250643) | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025-11-20 |
| HardyDisk AST Cefiderocol 30µg (FDC30) (K253105) | Hardy Diagnostics | 2025-11-20 |
| Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070) | Medline Industries, LP | 2025-11-20 |
| ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197) | Depuy Ireland UC | 2025-11-19 |
| LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (K253073) | Sunglor Technology Co., Ltd. | 2025-11-19 |
| OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun (K250651) | Fisher & Paykel Healthcare, Ltd. | 2025-11-19 |
| SternaFuse Ti Fixation System (K252661) | Fusion Innovations, LLC | 2025-11-19 |
| MyPAO SA guides (K242603) | Medacta International S.A. | 2025-11-19 |
| Focal One® (K251910) | Edap Technomed, Inc. | 2025-11-19 |
| IPL Hair Removal Device (SYL001AZ, SYL002AZ) (K253035) | Gu'An Yeolight Smart Electronics Co., Ltd. | 2025-11-19 |
| IntelliSep Test (K250912) | Cytovale, Inc. | 2025-11-19 |
| Microcurrent Facial Device (CEC101, EEI101) (K252642) | Shenzhen Dachi Communication Co., Ltd. | 2025-11-19 |
| LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (K250642) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| Guided Aarhus Applicator Set (K252884) | Varian Medical Systems | 2025-11-19 |
| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K252281) | Ulrich GmbH & Co. KG | 2025-11-18 |
| Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) (K251695) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (K252582) | Prismatik Dentalcraft, Inc. | 2025-11-18 |
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| Hexoskin Medical System (7100-00016) (K243981) | Carre Technologies, Inc. | 2025-11-18 |
| LifeStyles® HydraFeel Natural Rubber Latex Condom (K252521) | Suretex Limited | 2025-11-18 |
| Universal Spinal System (K252729) | Double Medical Technology, Inc. | 2025-11-18 |
| ToeJack MIS Bunion System (K253423) | Nvision Biomedical Technologies, Inc. | 2025-11-18 |
| Collagen Dura Regeneration Membrane - Repair (K251191) | Collagen Matrix, Inc. | 2025-11-18 |
| Fluido Compact System (K252636) | The Surgical Company International B.V. | 2025-11-18 |
| SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (K252550) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 |
| Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) (K251693) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| Miniature Telescope for Urology (27033AA) (K253411) | Karl Storz SE & CO. KG | 2025-11-18 |