| K253698 — Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251318 — VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252537 — Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253998 — Clearview Intracoronary Shunts | Medtronic, Inc. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. Sun Jan 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254114 — Baylis Connector Cable | Baylis Medical Technologies, Inc. Sun Jan 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland Sat Jan 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253363 — NeuroSpan Bridge | Auxilium Biotechnologies, Inc. Sat Jan 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251721 — Xpert GI Panel | Cepheid Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251448 — FL-10000U Respiratory Humidifier | Flexicare Medical Limited. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251934 — qXR-Detect | Qure.Ai Technologies Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252767 — actiTENS mini | Sublimed Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251790 — SeptAlign | Spirair, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252960 — SOLIUS PRO UVB Light Panel | Solius Labs, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250135 — WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253082 — LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251341 — VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251367 — OptoMonitor 3 | Opsens, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251714 — Ion-C | SurGenTec, LLC Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251900 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252634 — Imagine® Enterprise Suite | Softlink International Private Limited Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254186 — Azurion R3.1 | Philips Medical Systems B.V. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252297 — Toro 88 Superbore Catheter | Toro Neurovascular, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251249 — Tru Hematology Test | Truvian Sciences, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254126 — Natrelle 133S Tissue Expanders | AbbVie Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253408 — CoolTone | Zimmer Medizinsysteme GmbH Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250005 — Sana Device | Sana Health Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251353 — Eyer 2 | Phelcom Technologies Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251739 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252516 — N22 EZ Glenosphere | Shoulder Innovations, Inc. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251831 — Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251254 — Ignite RF System | InMode , Ltd. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251357 — Esperance pHLO Aspiration System | Phenox, Ltd. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253023 — BIOGRAPH One | Siemens Healthineers AG Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252283 — Nano-Check Influenza A+B Test | Nano-Ditech Corporation Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252567 — AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251961 — SDS Growing Rod | BAAT Medical Products B.V. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |