| K240999 — Legend X Applicator VO | Pollogen, Ltd. May 8, 2024 |
| K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation May 8, 2024 |
| K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. May 7, 2024 |
| K234018 — CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | Dentsply Sirona May 7, 2024 |
| K233695 — Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. May 7, 2024 |
| K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. May 7, 2024 |
| K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG May 7, 2024 |
| K233766 — Geneo X Elite | Pollogen, Ltd. May 7, 2024 |
| K240377 — LIFEPAK® ECG Cables | Stryker Physio-Control May 7, 2024 |
| K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. May 7, 2024 |
| K231612 — Eve Patient Positioner System | Leo Cancer Care May 7, 2024 |
| K232928 — DeepContour (V1.0) | Wisdom Technologies., Inc. May 7, 2024 |
| K233864 — ASSURE Wearable ECG | Kestra Medical Technologies, Inc. May 7, 2024 |
| K232833 — HALO AP Dx | Indica Labs, Inc. May 7, 2024 |
| K232514 — MIM Dose Analysis | Mim Software, Inc. May 6, 2024 |
| K240392 — JAZZ Spinal System | Implanet May 6, 2024 |
| K240007 — Solar Compact (G4-1) | Laborie Medical Technologies, Corp. May 6, 2024 |
| K240685 — Salvo® Spine System | Spine Wave, Inc. May 6, 2024 |
| K233800 — Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. May 6, 2024 |
| K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC May 6, 2024 |
| K234088 — Emily's Care Nourish Test System (Model 1) | Lactation Lab, Inc. May 3, 2024 |
| K232735 — EMA 3D | Ema Sleep Incorporated May 3, 2024 |
| K233524 — Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | Hollister Incorporated May 3, 2024 |
| K233157 — VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC May 3, 2024 |
| K232454 — Viral Transport Media (VTM) | Alb Luz May 3, 2024 |
| K240126 — ProAM ALIF System | Pro Surgical, Inc. May 3, 2024 |
| K233349 — Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. May 3, 2024 |
| K232491 — CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. May 3, 2024 |
| K240800 — Access Intrinsic Factor Ab | Beckman Coulter, Inc. May 3, 2024 |
| K240185 — Cypris eXact Suture Placement Device | Cypris Medical May 3, 2024 |
| K233687 — ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation May 3, 2024 |
| K240625 — CORUS Navigation Access System | Providence Medical Technology, Inc. May 3, 2024 |
| K240940 — Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. May 3, 2024 |
| K232941 — Megaloop Button System | Suzhou Endophix Co., Ltd. May 3, 2024 |
| K240919 — Silk Voice (SMI-04) | Sofregen Medical May 3, 2024 |
| K232895 — B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd May 3, 2024 |
| K232648 — RODEO Telescopic Nail | Orthofix Srl May 3, 2024 |
| K232733 — Mbrace Cable | Medacta International S.A. May 3, 2024 |
| K240297 — Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC May 3, 2024 |
| K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | Outset Medical, Inc. May 3, 2024 |
| K232416 — AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. May 3, 2024 |
| K234021 — Masimo Stork | Masimo Corporation May 3, 2024 |
| K233752 — Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | CenterPoint Systems, LLC May 2, 2024 |
| K240037 — Revi System | Bluewind Medical , Ltd. May 2, 2024 |
| K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | Contec Medical Systems Co.,Ltd May 2, 2024 |
| K240636 — HemoScreen Hematology Analyzer | Pixcell Medical Technologies May 2, 2024 |
| K233689 — Hope&Her Vaginal Dilators | Lujena, Inc. May 2, 2024 |
| K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. May 2, 2024 |
| K232445 — CSF-4 (CSF-4) | Cardiacsense May 2, 2024 |
| K240012 — Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd May 2, 2024 |