| K252565 — PreOp v3 | Clouds Of Care Feb 13, 2026 |
| K253092 — Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. Feb 13, 2026 |
| K253096 — Chartis Precision Catheter | Pulmonx Corporation Feb 13, 2026 |
| K251619 — Babyleo TN500 | Drägerwerk AG & Co. KGaA Feb 13, 2026 |
| K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. Feb 13, 2026 |
| K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. Feb 13, 2026 |
| K252422 — Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. Feb 13, 2026 |
| K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics Feb 12, 2026 |
| K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG Feb 12, 2026 |
| K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. Feb 12, 2026 |
| K254007 — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. Feb 12, 2026 |
| K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. Feb 12, 2026 |
| K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC Feb 12, 2026 |
| K251732 — Wrist Fracture System | Met One Technologies, LLC Feb 12, 2026 |
| K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics Feb 12, 2026 |
| K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. Feb 12, 2026 |
| K260177 — Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. Feb 12, 2026 |
| K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. Feb 12, 2026 |
| K251375 — PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. Feb 12, 2026 |
| K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. Feb 12, 2026 |
| K260108 — L12 LED Light Source with AIM | Stryker Endoscopy Feb 12, 2026 |
| K253032 — AXS Lift Intracranial Base Catheter | Stryker Neurovascular Feb 11, 2026 |
| K252084 — AI4CMR v2.0 | Ai4Medimaging Medical Solutions S.A. Feb 11, 2026 |
| K251592 — SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical Feb 11, 2026 |
| K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Feb 11, 2026 |
| K251813 — CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH Feb 11, 2026 |
| K253488 — iFuse INTRA Ti Implant System | SI-BONE, Inc. Feb 11, 2026 |
| DEN250007 — Delivery Date AI | Ultrasound AI Feb 11, 2026 |
| K251992 — ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. Feb 11, 2026 |
| K253545 — Vulcan Spinal System | K2M, Inc. Feb 10, 2026 |
| K251672 — NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. Feb 10, 2026 |
| K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC Feb 10, 2026 |
| K252175 — LANDR Contact LENS Case | Fourth Axis, LLC Feb 10, 2026 |
| K260119 — SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation Feb 10, 2026 |
| K254016 — MI View&GO | Siemens Medical Solutions USA, Inc. Feb 10, 2026 |
| K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. Feb 10, 2026 |
| K253140 — CollOvine Wound Powder | Ovigenex, LLC Feb 10, 2026 |
| K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. Feb 10, 2026 |
| K252751 — Earflo (EF001) | Earflo, Inc. Feb 10, 2026 |
| K251515 — Solidex® Ti-Links and Screws | CreoDent Hudson Valley Feb 10, 2026 |
| K254236 — Peel-Away Introducer Sheath | VascuTech Medical, LLC Feb 9, 2026 |
| K251591 — Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. Feb 9, 2026 |
| K254033 — Ceribell Instant EEG Headset | Ceribell, Inc. Feb 9, 2026 |
| K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. Feb 6, 2026 |
| K251218 — SafeBeat Rx App | SafeBeat Rx, Inc. Feb 6, 2026 |
| K243348 — Athelas Home | Athelas, Inc. Feb 6, 2026 |
| K251614 — Stainless Steel Surgical Kits | Dentsply Sirona, Inc. Feb 6, 2026 |
| K252873 — Q Interbody Instruments | K2M, Inc. Feb 6, 2026 |
| K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC Feb 6, 2026 |
| K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation Feb 6, 2026 |