| K243567 — Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. Apr 7, 2025 |
| K250521 — NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. Apr 7, 2025 |
| K250033 — Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. Apr 7, 2025 |
| K250395 — BioBrace ® RC Delivery System | Conmed Corporation Apr 7, 2025 |
| K250425 — Ultraviolet Phototherapy Device | APK Technology Co., Ltd. Apr 7, 2025 |
| K242209 — UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. 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 |
| K243549 — JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL 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 |
| K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa Apr 4, 2025 |
| K243769 — QFR (3.0) | Qfr Solutions BV Apr 4, 2025 |
| K250667 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Apr 4, 2025 |
| K243074 — Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. Apr 4, 2025 |
| K242807 — HeartFocus (V.1.1.1) | Deski Apr 4, 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 |
| K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical Apr 4, 2025 |
| K243236 — WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. 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 |
| K243691 — LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. Apr 4, 2025 |
| K242116 — EyeBOX EBX-4.1 | Oculogica, Inc. Apr 4, 2025 |
| K250656 — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co., Ltd. Apr 4, 2025 |
| K250332 — Virage® OCT Spinal Fixation System | Highridge Medical, LLC 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 |
| K242576 — AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. Apr 4, 2025 |
| K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. Apr 4, 2025 |
| K242068 — LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd 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 |
| K250658 — SureFine Pen Needle | Shina Med Corporation Apr 3, 2025 |
| K243305 — Masimo W1 | Masimo Corporation Apr 3, 2025 |
| K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. Apr 3, 2025 |
| K242358 — Powered wheelchair (mobility robot) (M4, M4U) | Xsto Co., Ltd. Apr 3, 2025 |
| K243514 — Salvo® Robotic Navigation Instruments | Spine Wave, Inc. Apr 3, 2025 |
| K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. Apr 3, 2025 |
| K243298 — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | Carbon (Shenzhen) Medical Device Co., Ltd. Apr 3, 2025 |
| K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC Apr 3, 2025 |
| K242551 — syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH Apr 3, 2025 |
| K240615 — Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. Apr 3, 2025 |
| K250705 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Apr 2, 2025 |
| K241984 — Hi-D Imaging 4TAVR | Hi-D Imaging AG Apr 2, 2025 |
| K242114 — Plum Solo Precision IV Pump | Icu Medical, Inc. Apr 2, 2025 |
| K243733 — SION blue PLUS | Asahi Intecc Co., Ltd. Apr 2, 2025 |
| K242113 — Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. Apr 2, 2025 |
| K250138 — Small Volume 0.2mL Syringe | Prosum Medical Limited Apr 2, 2025 |
| K250613 — SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. Apr 2, 2025 |
| K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation Apr 2, 2025 |
| K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations Of The Americas Apr 2, 2025 |
| K250930 — twiist system | Deka Research & Development Corp. Apr 2, 2025 |
| K242460 — Progenix Select Stim | Progenix, LLC Apr 2, 2025 |