| Natrelle 133S Tissue Expanders (K254126) | AbbVie | 2026-01-16 |
| Eyer 2 (K251353) | Phelcom Technologies | 2026-01-16 |
| Aventus Thrombectomy System (K253925) | Inquis Medical | 2026-01-15 |
| AltiVate Reverse® ADLC Glenosphere (K252567) | Encore Medical L.P. | 2026-01-15 |
| SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308) | Thera B Medical Products | 2026-01-15 |
| Ignite RF System (K251254) | InMode , Ltd. | 2026-01-15 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) (K253276) | Shanghai Bangbang Robotics Co., Ltd. | 2026-01-15 |
| Nano-Check Influenza A+B Test (K252283) | Nano-Ditech Corporation | 2026-01-15 |
| N22 EZ Glenosphere (K252516) | Shoulder Innovations, Inc. | 2026-01-15 |
| Diagnocat (K252934) | DGNCT, LLC | 2026-01-15 |
| Curiteva Porous PEEK Cervical Interbody Fusion System (K254061) | Curiteva, Inc. | 2026-01-15 |
| Esperance pHLO Aspiration System (K251357) | Phenox, Ltd. | 2026-01-15 |
| TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (K254002) | TriMed, Inc. | 2026-01-15 |
| Electric Wheelchair (DH01168) (K251458) | Foshan Dahao Medical Technology Co., Ltd. | 2026-01-15 |
| BIOGRAPH One (K253023) | Siemens Healthineers AG | 2026-01-15 |
| VitaSmart Hypothermic Oxygenated Perfusion System (DEN250009) | Bridge TO Life, Ltd. | 2026-01-15 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188) | Elekta Solutions AB | 2026-01-15 |
| SDS Growing Rod (K251961) | BAAT Medical Products B.V. | 2026-01-15 |
| Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171) | Maxx Orthopedics, Inc. | 2026-01-15 |
| MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (K253470) | Medtronic Minimed, Inc. | 2026-01-15 |
| dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (K254190) | Philips Medical Systems Nederland B.V. | 2026-01-14 |
| Cardinal Health Nitrile Examination Gloves Extended Cuff (K252313) | Cardinalhealth | 2026-01-14 |
| ENTire IRE System (K251996) | Entire Medical , Ltd. | 2026-01-14 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K251419) | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| Orthoscan TAU MVP Mini C-Arm System (K252579) | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| METICULY Patient-specific titanium mesh implant (K252958) | Meticuly Co., Ltd. | 2026-01-14 |
| Cervical Interbody and VBR Fusion System (K252219) | Sync Surgical | 2026-01-14 |
| SmartGuard technology; Predictive Low Glucose technology (K253585) | Medtronic Minimed, Inc. | 2026-01-14 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010) | Brainlab SE | 2026-01-14 |
| Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (K252549) | Kossan International Sdn Bhd | 2026-01-13 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K251214) | Miach Orthopaedics, Inc. | 2026-01-13 |
| Swedge™ Pedicle Screw Fixation System Bezier Rod (K252461) | Spinal Resources, Inc. | 2026-01-13 |
| Bright Cavity Liner (K253248) | Dmp Dental Industry S.A. | 2026-01-13 |
| VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K254001) | Spectrum Dynamics Medical, Ltd. | 2026-01-13 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K254014) | Stryker Endoscopy | 2026-01-13 |
| Any-Paste (K253167) | Mediclus Co., Ltd. | 2026-01-12 |
| Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (K251307) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 |
| DYNAMIS™ Navigation System (K252962) | Promethean Restorative, LLC | 2026-01-12 |
| Dr. Yglo Skin Tag Remover (K251524) | Theotclab Healthcare B.V. | 2026-01-12 |
| EmpowerRide NAVIGATOR (K251886) | Empower Ride, LLC | 2026-01-12 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| High speed air turbine handpiece (K251389) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| Precision AI Surgical Planning System (PAI-SPS) (K251558) | Precision AI Pty, Ltd. | 2026-01-12 |
| Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (K251388) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 |
| Break Wave (K252913) | Sonomotion, Inc. | 2026-01-12 |
| Star E900 Electric System (K251701) | Dentalez, Inc., Stardental Division | 2026-01-12 |
| Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (K252807) | Arthrex, Inc. | 2026-01-12 |
| Disposable Surgical Face Mask (3P00B, C2900) (K252830) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 |
| Boston iFace (Boston iFace) (K251988) | Boston Aesthetics, Inc. | 2026-01-12 |
| SafeOp 3: Neural Informatix System (K252842) | Alphatec Spine, Inc. | 2026-01-11 |
| Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (K253973) | Liaoning Upcera Co., Ltd. | 2026-01-09 |
| Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) (K253075) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-01-09 |
| Disposable Neonatal NIBP Cuff (U1681S-C51N) (K253964) | Unimed Medical Supplies, Inc. | 2026-01-09 |
| Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (K253142) | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 |
| iotaSOFT® Insertion System (K252339) | Iotamotion, Inc. | 2026-01-09 |
| ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (K252906) | Ethicon Endo-Surgery, LLC | 2026-01-09 |
| JARVIS Metaphyseal Stem (K254003) | FH Industrie | 2026-01-09 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K252206) | Nova Biomedical Corporation | 2026-01-09 |
| HemosIL Silica Clotting Time (K253957) | Instrumentation Laboratory (IL) Co. | 2026-01-09 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K253550) | GI Windows, Inc. | 2026-01-09 |
| Solo Pace Fusion System (SOLOFUSE1) (K252674) | Solo Pace, Inc. | 2026-01-09 |
| KabiHelp® Uno; KabiHelp® Advance plus (K251139) | Fresenius Kabi AG | 2026-01-09 |
| NextAR Hip Platform (K252847) | Medacta International S.A. | 2026-01-09 |
| Corvair Monza (K252589) | AliveCor, Inc. | 2026-01-09 |
| Core Metabolic (K251157) | Truvian Health | 2026-01-09 |
| ZENEX Implant System_R-System (K252585) | Izenimplant Co., Ltd. | 2026-01-08 |
| LOGIQ Totus (K253370) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-08 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
| Fetal Doppler U8-25, U9-25 (K252669) | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026-01-08 |
| Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (K251160) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 |
| View (K253639) | GE Healthcare | 2026-01-08 |
| Advantage-C™ Ti3D Cervical Interbody Fusion Device (K252711) | Intelivation Technologies | 2026-01-08 |
| 3DICOM MD Cloud (K253784) | Singular Health Pty, Ltd. | 2026-01-08 |
| Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (K252788) | Tornier, Inc. | 2026-01-08 |
| Titanium Interbody System (K253266) | Spine Innovation, LLC | 2026-01-08 |
| Vision-MR™ Diagnostic Catheter (K252794) | Imricor Medical Systems, Inc. | 2026-01-08 |
| BriefCase-Triage: CARE Multi-triage CT Body (K252970) | Aidoc Medical , Ltd. | 2026-01-07 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| Sangria™ Thrombectomy System (K251207) | Avantec Vascular Corporation | 2026-01-07 |
| Clear Aligner (SCF-3348) (K251454) | Beame Medical Technology (Shenzhen) Limited | 2026-01-07 |
| SmileInspector (K252507) | Amv Consulting, LLC | 2026-01-07 |
| LOGIQ Fortis (K253366) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-01-07 |
| ZenSeal Pro (K252890) | Kerr Corporation | 2026-01-07 |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308) | Materialise NV | 2026-01-07 |
| PuraStat (K253923) | 3-D Matrix Europe SAS | 2026-01-07 |
| Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (K253109) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 |
| DS Core Detect (K253009) | Dentsply Sirona, Inc. | 2026-01-07 |
| VyBrate™ VBR System (K253158) | Vy Spine, LLC | 2026-01-07 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253990) | S.M.A.I.O | 2026-01-07 |
| PuraStat (K253924) | 3-D Matrix Europe SAS | 2026-01-07 |
| Reprocessed Agilis NxT Steerable Introducer (K250305) | Innovative Health | 2026-01-07 |
| Neodent InLab Validated Workflow (K252727) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 |
| Saans (F4-01-00-000-000) (K251165) | Innaccel Technologies Private Limited | 2026-01-06 |
| Materialise TKA Guide System (K253793) | Materialise NV | 2026-01-06 |
| QuadLock™ Fixation System (K253618) | Abanza Tecnomed S.L | 2026-01-06 |