| K260647 — SPECCHIO | El.En S.P.A. Apr 2, 2026 |
| K252229 — BELLIGER ACE | Genoray Co., Ltd. Apr 2, 2026 |
| K252079 — Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. Apr 2, 2026 |
| K260026 — Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics Apr 2, 2026 |
| K250518 — SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. Apr 2, 2026 |
| K252130 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Apr 2, 2026 |
| K252137 — BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Apr 2, 2026 |
| K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. Apr 2, 2026 |
| K253076 — Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd Apr 2, 2026 |
| 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. Apr 1, 2026 |
| K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl Apr 1, 2026 |
| K253586 — RM Electrode (RMH 25-01) | Retmap, Inc. Apr 1, 2026 |
| K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. Apr 1, 2026 |
| K253473 — Synchrony | Stereotaxis, Inc. Apr 1, 2026 |
| K254015 — CoLumbo C-Spine | Smart Soft Healthcare AD Apr 1, 2026 |
| 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. Apr 1, 2026 |
| 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 Apr 1, 2026 |
| K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited Apr 1, 2026 |
| K242303 — MOD-C | Orthomod, LLC Apr 1, 2026 |
| K253718 — enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. Apr 1, 2026 |
| K253582 — Medical Imaging Calibration Feature (MICF) | Apple, Inc. Apr 1, 2026 |
| K253405 — Prana System | Prana Surgical Apr 1, 2026 |
| K260191 — Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. Mar 31, 2026 |
| K260319 — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co., Ltd. Mar 31, 2026 |
| K253029 — RW-1 | Mediott, Inc. Mar 31, 2026 |
| K260375 — Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. Mar 31, 2026 |
| K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. Mar 31, 2026 |
| K253598 — InjecSURE Injection System | Carbon Medical Technologies, Inc. Mar 31, 2026 |
| K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine Mar 30, 2026 |
| K252158 — Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories Mar 30, 2026 |
| K260370 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. Mar 30, 2026 |
| K252269 — FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. Mar 30, 2026 |
| K253950 — Avatar Medical Vision | Avatar Medical Mar 30, 2026 |
| K253654 — IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH Mar 30, 2026 |
| K254122 — FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation Mar 30, 2026 |
| K254207 — AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. Mar 30, 2026 |
| K260812 — Francisella tularensis Real-time PCR Assay | Centers For Disease Control And Prevention Mar 30, 2026 |
| K260037 — implantcast Packaging System Update | Implantcast GmbH Mar 30, 2026 |
| K252360 — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. Mar 28, 2026 |
| K260257 — CO2 Laser System | Sanhe Meditech Co., Ltd. Mar 28, 2026 |
| K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. Mar 27, 2026 |
| K253649 — Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. Mar 27, 2026 |
| K260041 — MDx-Chex for BCP | Streck, LLC Mar 27, 2026 |
| K252064 — MedCAD® AccuStride System | Medcad Mar 27, 2026 |
| K253307 — Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. Mar 27, 2026 |
| K253980 — Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. Mar 27, 2026 |
| K253392 — Synergy Disc Instruments | Synergy Spine Solutions, Inc. Mar 27, 2026 |
| K260294 — SF Push-in Anchor | Surgical Fusion Technologies GmbH Mar 27, 2026 |
| K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Mar 27, 2026 |
| K252195 — ARTICOR planner | Artiness S.R.L Mar 27, 2026 |