| K250233 — PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252422 — Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260130 — Willow 18 Guidewire | Arbor Endovascular, LLC Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252565 — PreOp v3 | Clouds of Care Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254105 — Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252400 — Endomina EZFuse system | Endo Tools Therapeutics S.A. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252420 — Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251619 — Babyleo TN500 | Drägerwerk AG & Co KGaA Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253096 — Chartis Precision Catheter | Pulmonx Corporation Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251802 — STAR RF Ablation System | Merit Medical Systems, Inc. Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243854 — Contour Light (CL-100) | Contour Research, LLC Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251742 — VELO Respiratory Test | Lex Diagnostics Limited Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253149 — Motion InBra (YM-8801) wearable breast pump | Medela, LLC Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252512 — Armada 14 NC PTA Catheter | Abbott Medical Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254007 — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260177 — Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific, LLC Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260108 — L12 LED Light Source with AIM | Stryker Endoscopy Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251732 — Wrist Fracture System | Met One Technologies, LLC Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251375 — PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Thu Feb 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253032 — AXS Lift Intracranial Base Catheter | Stryker Neurovascular Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250007 — Delivery Date AI | Ultrasound AI Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252084 — AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251813 — CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253488 — iFuse INTRA Ti Implant System | SI-BONE, Inc. Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251592 — SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251992 — ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253545 — Vulcan Spinal System | K2m, Inc. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253140 — CollOvine Wound Powder | Ovigenex, LLC Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |