| K254176 — SINEFIX | BAAT Medical Products B.V. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252122 — DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253838 — Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254079 — LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253705 — Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Technomed Europe Sun Mar 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253261 — Apollo Quattro (APQ-10M) | Weero Co., Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252923 — IASIS i2 Relaxation Neurofeedback System | Iasis Technologies Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252249 — Extremity CT Imaging System | Mars Bioimaging , Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251999 — Promogran Prisma Collagen Matrix with ORC and Silver | Solventum Germany GmbH Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260479 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253111 — Aeka Imaging | Good Methods Global, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260499 — Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260078 — Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252261 — InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253987 — BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252648 — Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254277 — Embrace Neonatal MRI System | Aspect Imaging, Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254059 — Access anti-HBc IgM | Beckman Coulter, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253732 — Permatage Flowable, Settable Bone Paste | Orthocon, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251848 — Pentacam® Cornea OCT | Oculus Optikgeräte GmbH Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251916 — GenBody COVID-19 Ag Home Test | Genbody.Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260455 — New Wave System | Zeto, Inc. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253429 — Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250655 — Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253062 — Tigertriever 25 Revascularization Device | Rapid Medical , Ltd. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254233 — MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251584 — Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260502 — Liv Pre-lubricated Intermittent Catheter | HR Healthcare Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253636 — Zionic Pro Max (EMS) | Termosalud S.L. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252546 — VantageTM Lumbar Decompression Kit | Allevion Medical, LLC Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252401 — implaFit® short stems | Implantcast GmbH Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250794 — InVera Infusion Device | Invera Medical Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253525 — Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251964 — Mimics Thoracic Planner | Materialise NV Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253566 — Affixus Retrograde Femoral Nailing System | Zimmer, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251750 — Trax EX Anchor | Trax Surgical, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253743 — MiniMed Flex pump | Medtronic Minimed, Inc. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252089 — Tyto Stethoscope (G3) | Tyto Care , Ltd. Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |