| K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | Owens & Minor (O&M) Halyard, Inc. Jun 21, 2024 |
| K233096 — PRESSUREALERT® Pressure Monitoring System | Position Health, LLC Jun 21, 2024 |
| K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. Jun 21, 2024 |
| K233549 — Tempus ECG-AF | Tempus AI, Inc. Jun 21, 2024 |
| K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. Jun 21, 2024 |
| K233253 — eCARTv5 Clinical Deterioration Suite (eCART) | Agilemd, Inc. Jun 21, 2024 |
| K233280 — SteadyTemp | Steadysense GmbH Jun 21, 2024 |
| K234095 — OtoNova/OtoNova Pro | Otodynamics Jun 21, 2024 |
| K233230 — See Factor CT3 | Epica International, Inc. Jun 21, 2024 |
| K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Guangzhou Red Pine Medical Instrument Co., Ltd. Jun 21, 2024 |
| K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. Jun 21, 2024 |
| K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. Jun 21, 2024 |
| K232975 — Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. Jun 21, 2024 |
| K233361 — Sunny Cup and Applicator | Menstrual Mates Jun 21, 2024 |
| K233322 — Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. Jun 21, 2024 |
| K240125 — Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations Jun 21, 2024 |
| K240830 — Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Orthofix Medical, Inc. Jun 20, 2024 |
| K240673 — Electric wheelchair | Zhejiang Hfizer Medical Equipment Co., Ltd. Jun 20, 2024 |
| K241435 — Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | Smith & Nephew, Inc. Jun 20, 2024 |
| K233158 — Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH Jun 20, 2024 |
| K240669 — ACTIFY 3D Total Knee System, ACTIFY Total Knee System | Globus Medical, Inc. Jun 20, 2024 |
| K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation Jun 20, 2024 |
| K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. Jun 20, 2024 |
| K241627 — Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. Jun 20, 2024 |
| K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC Jun 20, 2024 |
| K240611 — IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Ivylaser (Beijing) Technology Co.,Ltd Jun 20, 2024 |
| K233162 — Freedom Peripheral Nerve Stimulator (PNS) System | Curonix Jun 20, 2024 |
| K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | Schoelly Fiberoptic GmbH Jun 20, 2024 |
| K240642 — SMART Bun-Yo-Matic CT | Disior, Ltd. Jun 20, 2024 |
| K240613 — APTUS Elbow Dorsal Olecranon Plates | Medartis AG Jun 20, 2024 |
| K240688 — RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak Jun 20, 2024 |
| K232161 — DeepRhythm Platform | Medicalgorithmics S.A. Jun 20, 2024 |
| K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation Jun 19, 2024 |
| K240774 — Pen Injector | Wuxi Nest Biotechnology Co., Ltd. Jun 18, 2024 |
| K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) | Yuwonmeditech Co., Ltd. Jun 18, 2024 |
| K233036 — Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. Jun 18, 2024 |
| K241412 — Invisalign System | Align Technology, Inc. Jun 18, 2024 |
| K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH Jun 18, 2024 |
| K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC Jun 18, 2024 |
| K240552 — Irrisept Antimicrobial Wound Lavage | Irrimax Corporation Jun 18, 2024 |
| K233867 — Fitbone Trochanteric | Orthofix Srl Jun 18, 2024 |
| K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation Jun 18, 2024 |
| K240583 — IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. Jun 18, 2024 |
| K233331 — MediOMx | Pmx, Inc. Jun 17, 2024 |
| K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. Jun 17, 2024 |
| K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC Jun 17, 2024 |
| K240747 — Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. Jun 17, 2024 |
| K233256 — Robotic Integration Instruments | DePuy Synthes Jun 17, 2024 |
| K240684 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 17, 2024 |
| K233324 — Molecular Transport Media - MTM | Alb Luz Jun 17, 2024 |