| K251934 — qXR-Detect | Qure.Ai Technologies Jan 16, 2026 |
| K251790 — SeptAlign | Spirair, Inc. Jan 16, 2026 |
| K251900 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Jan 16, 2026 |
| K251714 — Ion-C | SurGenTec, LLC Jan 16, 2026 |
| K252634 — Imagine® Enterprise Suite | Softlink International Private Limited Jan 16, 2026 |
| K254126 — Natrelle 133S Tissue Expanders | AbbVie Jan 16, 2026 |
| K253408 — CoolTone | Zimmer Medizinsysteme GmbH Jan 16, 2026 |
| K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical Jan 16, 2026 |
| DEN250005 — Sana Device | Sana Health Jan 16, 2026 |
| K251353 — Eyer 2 | Phelcom Technologies Jan 16, 2026 |
| K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. Jan 16, 2026 |
| K251739 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Jan 16, 2026 |
| K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic Jan 16, 2026 |
| K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB Jan 15, 2026 |
| K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation Jan 15, 2026 |
| K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. Jan 15, 2026 |
| K251254 — Ignite RF System | InMode , Ltd. Jan 15, 2026 |
| K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products Jan 15, 2026 |
| K251831 — Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. Jan 15, 2026 |
| K252516 — N22 EZ Glenosphere | Shoulder Innovations, Inc. Jan 15, 2026 |
| K251357 — Esperance pHLO Aspiration System | Phenox, Ltd. Jan 15, 2026 |
| DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. Jan 15, 2026 |
| K253023 — BIOGRAPH One | Siemens Healthineers AG Jan 15, 2026 |
| K252283 — Nano-Check Influenza A+B Test | Nano-Ditech Corporation Jan 15, 2026 |
| K252567 — AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. Jan 15, 2026 |
| K251961 — SDS Growing Rod | BAAT Medical Products B.V. Jan 15, 2026 |
| K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. Jan 15, 2026 |
| K254002 — 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) | TriMed, Inc. Jan 15, 2026 |
| K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. Jan 15, 2026 |
| K253925 — Aventus Thrombectomy System | Inquis Medical Jan 15, 2026 |
| K252934 — Diagnocat | DGNCT, LLC Jan 15, 2026 |
| K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. Jan 15, 2026 |
| K251458 — Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. Jan 15, 2026 |
| K253511 — Concerto Versa Detachable Coil | Medtronic, Inc. Jan 14, 2026 |
| K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. Jan 14, 2026 |
| K252958 — METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. Jan 14, 2026 |
| K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth Jan 14, 2026 |
| K251996 — ENTire IRE System | Entire Medical , Ltd. Jan 14, 2026 |
| K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. Jan 14, 2026 |
| K252219 — Cervical Interbody and VBR Fusion System | Sync Surgical Jan 14, 2026 |
| K253585 — SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. Jan 14, 2026 |
| K252579 — Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. Jan 14, 2026 |
| K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE Jan 14, 2026 |
| K253248 — Bright Cavity Liner | Dmp Dental Industry S.A. Jan 13, 2026 |
| K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy Jan 13, 2026 |
| K252549 — 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 | Kossan International Sdn Bhd Jan 13, 2026 |
| K251214 — BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. Jan 13, 2026 |
| K252461 — Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. Jan 13, 2026 |
| K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. Jan 13, 2026 |
| K251389 — High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. Jan 12, 2026 |