| K252270 — Hemoclip | Hangzhou AGS MedTech Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260089 — TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252224 — Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260477 — CATAMARAN SI Joint Fusion System | Tenon Medical Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253534 — Pivot Insulin Delivery System | Modular Medical Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | Shenzhen Root Innovation Technology Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253268 — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260033 — Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260197 — Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260766 — Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260942 — AuST Steerable Sheath | CenterPoint Systems, LLC Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252861 — Warming System | Hangzhou Tappa Medical Technology Co., Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260048 — Elecsys Anti-HAV IgM | Roche Diagnostics Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260049 — Elecsys Anti-HBc IgM | Roche Diagnostics Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253952 — Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253801 — ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253905 — PrimeSight UltraView System | Cogentix Medical, Inc. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254191 — IWD-Gel | InnovaCorium, Inc. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260046 — Elecsys Anti-HBc II | Roche Diagnostics Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252979 — Voyager DSLT (430840610) | Belkin Vision, Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252116 — Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252809 — in2 Smart (in2S) | Virility Medical , Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252182 — SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253862 — APERTO Lucent MRI System | Fujifilm Corporation Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250208 — SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254091 — GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260459 — VANES Delivery System (VDS) | Zoll Respicardia, Inc. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253025 — Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254084 — AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253036 — Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. Mon Apr 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254066 — Etiometry Platform | Etiometry, Inc. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253340 — Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260363 — Ceribell Brain Monitor Headband | Ceribell, Inc. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240071 — neuropacs | Automated Imaging Diagnostics, LLC Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260524 — uMI Panvivo (uMI Panvivo LS); 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 Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254153 — Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260724 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250074 — HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253042 — Tyber Medical Trauma Screw | Tyber Medical, LLC Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |