| K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi Ve Ticaret Anonim Sirketi May 8, 2026 |
| K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl May 8, 2026 |
| K253396 — AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation May 8, 2026 |
| K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. May 7, 2026 |
| K253826 — Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | Galvanize Therapeutics, Inc. May 7, 2026 |
| K254183 — MR Conditional Cup Electrodes | Technomed Europe May 7, 2026 |
| K260974 — CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. May 7, 2026 |
| K253992 — Veritas Reverse Total Shoulder System | Restor3D May 7, 2026 |
| K260460 — Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG May 7, 2026 |
| K254276 — Lynx Aspiration Catheter System | QApel Medical, Inc. May 7, 2026 |
| K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH May 7, 2026 |
| K253647 — Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa May 7, 2026 |
| K253027 — Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. May 6, 2026 |
| K260775 — Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | Teleflex Medical, LLC May 6, 2026 |
| K261112 — CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. May 6, 2026 |
| K260376 — Denture Base | Shandong Huge Dental Material Corporation May 6, 2026 |
| K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC May 6, 2026 |
| K253855 — KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; Dba Corvention May 6, 2026 |
| K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. May 6, 2026 |
| K260747 — YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation May 6, 2026 |
| K261130 — AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. May 5, 2026 |
| K261132 — Healium Intelliscan LX192LC | Healium Intelliscan Corporation May 5, 2026 |
| K254202 — MectaLIF 3D Metal Anterior | Medacta International S.A. May 5, 2026 |
| K252558 — Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC May 5, 2026 |
| K254200 — Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) | Wenzhou Lingfeng Electronic Technology Co., Ltd. May 5, 2026 |
| K260742 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | Shenzhen Ulike Smart Electronics Co., Ltd. May 5, 2026 |
| K253251 — Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu May 4, 2026 |
| K260256 — Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. May 4, 2026 |
| K260716 — Neowise | Cefla S.C. May 4, 2026 |
| K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | Amsino International, Inc. May 4, 2026 |
| K254019 — Wound Geni NPWT System | Bechtel Medical, Inc. May 4, 2026 |
| K254115 — ArteraAI Breast | Artera, Inc. May 4, 2026 |
| K252954 — MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) May 4, 2026 |
| K252622 — Male Latex Condom HA | Okamoto USA, Inc. May 4, 2026 |
| K260688 — Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. May 4, 2026 |
| K254234 — Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. May 1, 2026 |
| K260819 — Any-Com Seal | Mediclus Co., Ltd. May 1, 2026 |
| K252488 — ABL90 FLEX PLUS System | Radiometer Medicals Aps May 1, 2026 |
| K254139 — BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. May 1, 2026 |
| K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC May 1, 2026 |
| K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme May 1, 2026 |
| K254077 — OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. May 1, 2026 |
| K253326 — Oxiplex | Fziomed, Inc. May 1, 2026 |
| K252635 — ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC May 1, 2026 |
| K252475 — ABL90 FLEX PLUS System | Radiometer Medicals Aps May 1, 2026 |
| K261074 — BIOMONITOR IV (471155) | Biotronik, Inc. May 1, 2026 |
| K254154 — FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. May 1, 2026 |
| K252439 — Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. May 1, 2026 |
| DEN240075 — Prolystica Pass Thru Disinfectant Wipes | Steris May 1, 2026 |
| K261045 — Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. May 1, 2026 |