| K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. Mar 22, 2024 |
| K231926 — NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. Mar 22, 2024 |
| K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part Of Thermo Fisher Scientific) Mar 22, 2024 |
| K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. Mar 22, 2024 |
| K233578 — BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC Mar 22, 2024 |
| DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. Mar 22, 2024 |
| K233148 — Augment Off-Axis Instrument System | Fix Surgical Mar 22, 2024 |
| K240522 — Esophageal TTS Stent | Taewoong Medical Mar 22, 2024 |
| K232169 — FITBONE® Transport and Lengthening System | Orthofix Srl Mar 22, 2024 |
| K240540 — uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. Mar 22, 2024 |
| K232439 — Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. Mar 21, 2024 |
| K234062 — APTUS Hand Scaphoid Plates | Medartis AG Mar 21, 2024 |
| K230088 — Ankle Truss System (ATS) | 4Web Medical, Inc. Mar 21, 2024 |
| K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Ipg Medical Corporation Mar 21, 2024 |
| K233753 — AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH Mar 21, 2024 |
| K233926 — accufit | Mettler Electronics Corporation Mar 21, 2024 |
| K240309 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Mar 21, 2024 |
| K240530 — DynaNail Mini Tapered Hybrid | MedShape, Inc. Mar 21, 2024 |
| K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions Mar 21, 2024 |
| K240122 — Normatec Elite | NormaTec Industries, LP Mar 21, 2024 |
| K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC Mar 21, 2024 |
| K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | DePuy Synthes Mar 21, 2024 |
| K240754 — N2 | Megagen Implant Co., Ltd. Mar 21, 2024 |
| K234081 — RedDrop ONE (One) | Reddrop DX Mar 21, 2024 |
| K240253 — Reach Needle | Aerin Medical, Inc. Mar 21, 2024 |
| K240179 — Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. Mar 21, 2024 |
| K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. Mar 20, 2024 |
| K234052 — Access Ferritin | Beckman Coulter, Inc. Mar 20, 2024 |
| K233375 — Tranquil-L Interbody System | Nexus Spine, LLC Mar 20, 2024 |
| K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory Mar 20, 2024 |
| K234049 — Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG Mar 20, 2024 |
| K232125 — V-PVP | Vitromed GmbH Mar 20, 2024 |
| K233642 — InMode RF System | InMode , Ltd. Mar 20, 2024 |
| K232654 — Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Mar 20, 2024 |
| K240574 — BruxZir® Radiant | Prismatik Dentalcraft, Inc. Mar 20, 2024 |
| K240507 — NuVasive AttraX Scaffold | Nuvasive, Inc. Mar 20, 2024 |
| K234047 — Automatic Registration | Brainlab AG Mar 20, 2024 |
| K240743 — Peak Universal Bond | Ultradent Products, Inc. Mar 20, 2024 |
| K233002 — BEED 2,5, BEED 3,8 | Excelsior Resources, LLC Mar 20, 2024 |
| K231974 — PATHFAST®hs-cTnI-II | Phc Corporation Mar 20, 2024 |
| K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH Mar 20, 2024 |
| K240537 — SMARTXIDE PRO | El.En S.P.A. Mar 20, 2024 |
| K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. Mar 20, 2024 |
| K232682 — Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. Mar 19, 2024 |
| K240668 — Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. Mar 19, 2024 |
| K234024 — HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Mar 19, 2024 |
| K231719 — Medical Surgical Mask | Azur Medical Company, Inc. Mar 19, 2024 |
| K233772 — Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. Mar 19, 2024 |
| K232619 — MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group Mar 19, 2024 |
| K233146 — Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. Mar 19, 2024 |