| K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251628 — Mandibular Advancement Device L07 | Dcstar, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253145 — Pre-Sutured Tendon | Rti Surgical, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252325 — Hair Growth Laser Cap | Cosmo Far East Technology Limited Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250666 — Alegria Flash CTD Screen | Zeus Scientific Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253144 — Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251030 — Sirona Advanced Imaging Suite | Sirona Medical Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250955 — XC11 ICE System, USA | Yorlabs, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252569 — Carrier XL Delivery Catheter | Balt USA, LLC Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251289 — WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251838 — Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253249 — TriALTIS Spine System | Medos International SARL Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250394 — Fine TTO | Bodycad Laboratories, Inc. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253034 — HemoSphere Stream Module | Edwards Lifesciences Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231897 — NeuroAlign software | Medivis, Inc. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253040 — Aevumed FASE Suture Anchor | Aevumed, Inc. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH Tue Oct 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252640 — VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252665 — brAIn Shoulder Positioning | Avatar Medical Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252155 — AVAVA Skin Treatment System | AVAVA, Inc. Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242827 — A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250911 — MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251832 — InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251778 — Remi Custom Night Guard | Remi Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251282 — StealthStation S8 Spine Software | Medtronic Navigation, Inc. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250145 — Biopsy Port Adapter | Endosound, Inc. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240076 — Modius Lean | Neurovalens Limited Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251673 — X9 Ultrasound System | X9, Inc. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250203 — SureAx-Guide | Sureax Medical, LLC Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250197 — Estremo Fibular Nail | Citieffe S.R.L. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250178 — Adin Customized Abutments | Adin Dental Implant Systems , Ltd. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252266 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252254 — Osteotomy Wedge System | Sinaptic Surgical Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250227 — JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252264 — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |