| K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253844 — AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253532 — TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251091 — Lipids | Truvian Health Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253325 — ZipToe Hammertoe Fusion System | Toetal Solutions Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science And Technology Co., Ltd. Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | Covidien, LLC Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251534 — Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253343 — Celebrace Software | Celebrace Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253342 — PICO-K | Speclipse, Inc. Wed Dec 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. Wed Dec 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253279 — Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC Wed Dec 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253349 — Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. Wed Dec 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251800 — Healgen® URS Test Strips | Healgen Scientific, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253675 — OsteoRemedies Hip Spacer System | Osteoremedies, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252835 — Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253091 — ART-Plan+ (v3.1.0) | Therapanacea Sas Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253239 — Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250004 — QIKCAP System | Hai Solutions Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253341 — Custom Abutments AS | Medentika GmbH Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253312 — OrangeCAD Med Abutments | Orangecad Med GmbH Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252379 — AIR Recon DL | Ge Medical Systems, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | DiaSorin, Inc. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252633 — UNITY DX (UDX) | Cylite Pty. , Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251978 — LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250476 — NizPlant Dental Implant System | Paragon Implant Mfg., LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253754 — Philips Lumea IPL | Philips Consumer Lifestyle B.V. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251958 — VEINOPLUS Back | Dynapulse Medical Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252187 — Aura Glide (FC40) | Aura Medical, LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254163 — VarioSurg 4 | Nakanishi, Inc. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253281 — UpDoc | Updoc, Inc. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253122 — Sim&Size | Sim&Cure Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252145 — GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC Tue Dec 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253222 — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. Mon Dec 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243342 — KP Protective Face Mask | Kp Trading Co., Ltd. Mon Dec 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. Mon Dec 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252361 — AccurECG Analysis System (v2.0) | Accurkardia, Inc. Mon Dec 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |