| K243743 — autoSCORE (V 2.0.0) | Holberg Eeg AS Apr 9, 2025 |
| K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. Apr 9, 2025 |
| K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. Apr 9, 2025 |
| K243819 — Luminopia | Luminopia, Inc. Apr 9, 2025 |
| K243613 — Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. Apr 9, 2025 |
| K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation Apr 9, 2025 |
| DEN240021 — Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) | Active Protective Technologies, Inc. Apr 9, 2025 |
| K250373 — ProLift Expandable Spacer System | Life Spine, Inc. Apr 9, 2025 |
| K250136 — Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. Apr 8, 2025 |
| K242151 — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | Shenzhen Nuon Medical Equipment Co., Ltd. Apr 8, 2025 |
| K243967 — ONE Nitrile Condom | Global Protection Corp. Apr 8, 2025 |
| K250343 — LuxCreo Clear Aligner System | LuxCreo, Inc. Apr 8, 2025 |
| K242295 — BunkerHill BMD | BunkerHill Health Apr 8, 2025 |
| K243722 — Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) | Selio Medical Limited Apr 8, 2025 |
| K250948 — TriMed Fusion Cup System | TriMed, Inc. Apr 8, 2025 |
| K243749 — Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. Apr 8, 2025 |
| K250708 — NPseal | Guard Medical, Inc. Apr 8, 2025 |
| K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. Apr 8, 2025 |
| K250366 — Electric Wheelchair (LW01301A07) | Anhui Longway Medical Technology Co., Ltd. Apr 8, 2025 |
| K242552 — Horos Mobile | Icat Solutions, Ltd. Apr 8, 2025 |
| K243143 — E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. Apr 7, 2025 |
| K250521 — NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. Apr 7, 2025 |
| K242385 — LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. Apr 7, 2025 |
| K250425 — Ultraviolet Phototherapy Device | APK Technology Co., Ltd. Apr 7, 2025 |
| K250395 — BioBrace ® RC Delivery System | Conmed Corporation Apr 7, 2025 |
| K243567 — Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. Apr 7, 2025 |
| K250033 — Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. Apr 7, 2025 |
| K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Biotronik, Inc. Apr 4, 2025 |
| K242576 — AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. Apr 4, 2025 |
| K250332 — Virage® OCT Spinal Fixation System | Highridge Medical, LLC Apr 4, 2025 |
| K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa Apr 4, 2025 |
| K250667 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Apr 4, 2025 |
| K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. Apr 4, 2025 |
| K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical Apr 4, 2025 |
| K242807 — HeartFocus (V.1.1.1) | Deski Apr 4, 2025 |
| K242001 — Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. Apr 4, 2025 |
| K242103 — TRIOS Ready Tip | 3Shape TRIOS A/S Apr 4, 2025 |
| K243769 — QFR (3.0) | Qfr Solutions BV Apr 4, 2025 |
| K243691 — LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. Apr 4, 2025 |
| K250656 — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co., Ltd. Apr 4, 2025 |
| K241982 — DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies, Inc. Apr 4, 2025 |
| DEN240031 — Prapela SVS hospital bassinet pad (model P01) | Prapela, Inc. Apr 4, 2025 |
| K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | Fresenius Medical Care Renal Therapies Group, LLC Apr 4, 2025 |
| K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. Apr 4, 2025 |
| K243236 — WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. Apr 4, 2025 |
| K242116 — EyeBOX EBX-4.1 | Oculogica, Inc. Apr 4, 2025 |
| K240398 — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) Apr 4, 2025 |
| K242068 — LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd Apr 4, 2025 |
| K243074 — Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. Apr 4, 2025 |
| K243549 — JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL Apr 4, 2025 |