| K251995 — Access anti-HAV IgM | Beckman Coulter, Inc. Tue Jan 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251195 — BriefCase-Triage | Aidoc Medical , Ltd. Tue Jan 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. Mon Jan 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251670 — MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. Mon Jan 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. Mon Jan 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252753 — Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda Sat Jan 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253633 — Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Sat Jan 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250741 — Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252568 — New Day Skin Spray | Silk Holdings, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252957 — Pneumo Dissector Hook | Ab Medica Sas Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253160 — Syntex Exam Gloves | Basic Medical Technology, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251351 — AccuContour 4.0 | Manteia Technologies Co., Ltd. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253738 — 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253285 — Elitone for Men | Elidah, Inc. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Fri Jan 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253735 — AV Vascular | Philips Medical Systems Nederland B.V. Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253253 — IPDmilled Blanks | Implant Protesis Dental 2004, S.L. Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251323 — Device 104 Particulate | Geistlich Pharma AG Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251511 — PhenoMATRIX | Copan Wasp Srl Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253498 — Pump In Style® Pro+ | Medela, LLC Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252307 — Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253652 — Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253315 — Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252984 — Perin Health System (PHD80060-2) | Perin Health Devices, LLC Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253057 — AI-Rad Companion Brain MR | Siemens Healthcare GmbH Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252369 — Boston Pico755 | Boston Aesthetics, Inc. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254165 — Infinity OCT System | Medtronic Sofamor Danek USA, Inc. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252977 — Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251286 — Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253730 — RoVo Mechanical Thrombectomy System | Verge Medical, Inc. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251281 — Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260170 — LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253998 — Clearview Intracoronary Shunts | Medtronic, Inc. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253698 — Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252537 — Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253173 — uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251318 — VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253291 — Excelsior System | Blue Ocean Global Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |