| K260363 — Ceribell Brain Monitor Headband | Ceribell, Inc. 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) |
| K252495 — LSSA (NP-200) | Newpong Co., Ltd. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254060 — Life Saving Tourniquet | TW Medical Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253674 — Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252386 — Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O 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) |
| K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260719 — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH Fri Apr 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253056 — Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. 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) |
| K253962 — ClearCheck (RADCC V2.7) | Radformation, Inc. 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) |
| 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) |
| K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252246 — Leforte MMF System | Jeil Medical Corporation Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260647 — SPECCHIO | El.En S.P.A. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252709 — Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254022 — FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260184 — Onclarity Self-Collection Kit | Becton, Dickinson and Company Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252079 — Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260026 — Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250518 — SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252130 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250516 — SMART M-CELL PRP Concentration System | Miracell Co., Ltd. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252137 — BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252229 — BELLIGER ACE | Genoray Co., Ltd. Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253076 — Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254015 — CoLumbo C-Spine | Smart Soft Healthcare AD Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253586 — RM Electrode (RMH 25-01) | Retmap, Inc. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260276 — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252513 — Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253473 — Synchrony | Stereotaxis, Inc. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242303 — MOD-C | Orthomod, LLC Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253718 — enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253582 — Medical Imaging Calibration Feature (MICF) | Apple, Inc. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253405 — Prana System | Prana Surgical Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited Wed Apr 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260191 — Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253029 — RW-1 | Mediott, Inc. Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260375 — Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253598 — InjecSURE Injection System | Carbon Medical Technologies, Inc. Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |