| K260717 — Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253774 — Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260594 — IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | Shenzhen Xiazhifeng Electronic Co., Ltd. Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252707 — Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252717 — MAASTRO Rectal Applicator Set | Varian Medical Systems Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260304 — WAVE PTA Balloon Catheter | WAVE Medical AG Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261071 — DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260577 — FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252985 — Laport | Sejong Medical Co., Ltd. Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254024 — MR5 Activ Pro | Multi Radiance Medical, Inc. Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253722 — LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251270 — Taperloc® Complete Hip Stem | Biomet, Inc. Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253309 — SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253831 — CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253454 — HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260522 — RhinAer+ Stylus | Aerin Medical, Inc. Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260100 — MOSES Raydar | Boston Scientific Corporation Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253295 — Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254109 — G-CEM UNIVERSAL | GC America, Inc. Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260840 — BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. Sat May 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253716 — uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253642 — Jada System (Jada-2002) | Organon, LLC Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261264 — Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | Bausch and Lomb Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252377 — NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254050 — Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254120 — SubtleHD-CT (1.x) | Subtle Medical, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252423 — NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252563 — Neurophet SCALE PET | Neurophet., Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253235 — Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253759 — cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250781 — Embryo Predict | Alife Health Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260989 — Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253935 — medXion NEXUS | medXion Technologies, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261289 — UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253756 — cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260771 — TruSelect 2.6 Microcatheter | Boston Scientific Corporation Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261273 — Neurophet AQUA | Neurophet., Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260506 — Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252624 — KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254028 — Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |