| K252996 — Universal 1417PI | Konica Minolta Healthcare Americas, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261175 — WHILL (WHILL Model C2) | Whill, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252963 — BTL-899TT | BTL Industries, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261366 — Virtus | Somnomed, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252987 — ADRx Admixture Device | Epic Medical Pte. , Ltd. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260406 — Brainomix 360 Hyperdensity | Brainomix Limited Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252937 — ThinkQA 3 | Dosisoft SA Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252323 — cobas pulse blood glucose monitoring system | Roche Diagnostics Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253688 — MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261207 — Exalta Proximal Tibia Plating System | Tyber Medical, LLC Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253015 — Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252932 — Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261204 — Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260653 — Dexter L6 System | Distalmotion SA Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253052 — Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254145 — Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253650 — Anura Mobile Core SDK (M1) | Nuralogix Corporation Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261209 — Ion-L | SurGenTec, LLC Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260174 — PROBEAT-CR | Hitachi High-Tech Corp. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261610 — Verge Microcatheter | Instylla, Inc. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250129 — AViTA Breast Pump | Avita Corporation Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251326 — Respiration Rate algorithm | Edwards Lifesciences, LLC Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260859 — Rosetta SM, Rosetta SP | Hass Corp. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260710 — FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253607 — UNEEG EpiSight System | Uneeg Medical A/S Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250839 — Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261251 — Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254121 — Colli-PeeDx Urine Collection Kit | DNA Genotek, Inc. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260855 — Profoject Safety Pen Needles | CMT Health PTE., Ltd. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261174 — RxSight® Insertion Device | Rxsight, Inc. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250690 — Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253919 — Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253192 — DeepXray Spina | Alpha Intelligence Manifolds, Inc. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253115 — LARS ACJ | Movmedix S.A.S. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260414 — Tech-Image Video Endoscope System | Tech-Image CO., LTD. Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261329 — Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260810 — Anteralign LS coverplate | Tyber Medical, LLC Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260614 — Tinnitus Therapy | Sivantos GmbH Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261016 — MSS - Humeral reverse liners extension | Medacta International, SA Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253165 — LAP-iX2N | Sejong Medical Co., Ltd. Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251251 — ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260564 — DESS Dental Smart Solutions | Terrats Medical SL Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |