| K240611 — IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Ivylaser (Beijing) Technology Co.,Ltd Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233162 — Freedom Peripheral Nerve Stimulator (PNS) System | Curonix Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | Schoelly Fiberoptic GmbH Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240642 — SMART Bun-Yo-Matic CT | Disior, Ltd. Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240613 — APTUS Elbow Dorsal Olecranon Plates | Medartis AG Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240688 — RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232161 — DeepRhythm Platform | Medicalgorithmics S.A. Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240673 — Electric wheelchair | Zhejiang Hfizer Medical Equipment Co., Ltd. Thu Jun 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation Wed Jun 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240774 — Pen Injector | Wuxi Nest Biotechnology Co., Ltd. Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) | Yuwonmeditech Co., Ltd. Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233036 — Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241412 — Invisalign System | Align Technology, Inc. Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240552 — Irrisept Antimicrobial Wound Lavage | Irrimax Corporation Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233867 — Fitbone Trochanteric | Orthofix Srl Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240747 — Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233256 — Robotic Integration Instruments | DePuy Synthes Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241416 — Ion 3D | SurGenTec, LLC Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233324 — Molecular Transport Media - MTM | Alb Luz Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233331 — MediOMx | Pmx, Inc. Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233987 — VERABAND | Arbor Medical Innovations, LLC Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233255 — CROSSNAV Navigation Enabled Instruments | DePuy Synthes Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233060 — Elecsys Folate III | Roche Diagnostics Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation Sat Jun 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231116 — Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Sat Jun 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233496 — EndeavorOTC | Akili Interactive Labs, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233228 — Spine Navigation and Robotic-Assistance Device | Ecential Robotics Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241083 — SIS System | Surgical Information Sciences, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) | Shenzhen Pango Medical Electronics Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241407 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230668 — Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) | Owens & Minor (O&M) Halyard, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233955 — Clarius OB AI | Clarius Mobile Health Corp. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241082 — INNOVERSE Navigation Instruments | Innosys Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240721 — ExcelsiusFlex | Globus Medical, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233254 — TELIGEN System Navigation Ready Instruments | DePuy Synthes Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233238 — Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241250 — 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233043 — Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland, Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233707 — HFT150 | Invent Medical Corporation Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |