| K240558 — NAVOYCDS | Algodx AB Jul 22, 2024 |
| K241119 — Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. Jul 22, 2024 |
| K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Jul 22, 2024 |
| K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. Jul 22, 2024 |
| K231133 — neo315 | Neoscan Solution GmbH Jul 22, 2024 |
| K241116 — Onycho Laser V | Terasysd&C, Inc. Jul 22, 2024 |
| K241482 — Kinos Total Ankle System | Restor3D Jul 22, 2024 |
| K240347 — PTG-05 | Zimmer Medizinsysteme GmbH Jul 21, 2024 |
| K240538 — Premium Teeth Resin | Formlabs Ohio, Inc. Jul 19, 2024 |
| K241809 — coactiv+ Antimicrobial Wound Gel | Kane Biotech, Inc. Jul 19, 2024 |
| K233979 — VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. Jul 19, 2024 |
| K233866 — Senhance Surgical System | Asensus Surgical, Inc. Jul 19, 2024 |
| K233976 — VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC Jul 19, 2024 |
| K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science And Technology Co., Ltd. Jul 19, 2024 |
| K240835 — Suture Button Repair System | Skeletal Dynamics, Inc. Jul 19, 2024 |
| K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. Jul 19, 2024 |
| K233917 — ICHOR 7F Embolectomy System (ICH-7F) | Ichor Jul 18, 2024 |
| K221495 — SOLID CLIP Single Use Clip Applier | Medscope Biotech Co., Ltd. Jul 18, 2024 |
| K240340 — Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. Jul 18, 2024 |
| K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. Jul 18, 2024 |
| K233768 — Papacarie Duo | Elevate Oral Care Jul 18, 2024 |
| K241206 — Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. Jul 18, 2024 |
| K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics Jul 18, 2024 |
| K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology Jul 18, 2024 |
| K241321 — Juliet® Ti LL Lumbar Interbody Device | Spineart SA Jul 18, 2024 |
| K241463 — Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | Suzhou Master Machinery Manufacturing Co.,Ltd Jul 18, 2024 |
| K212521 — Field Shield Wound Dressing | Kericure, Inc. Jul 18, 2024 |
| K241879 — vRad Viewer | Virtual Radiologic Corporation Jul 18, 2024 |
| K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. Jul 18, 2024 |
| K233482 — Equinoxe® Central Screw Baseplate System | Exactech, Inc. Jul 18, 2024 |
| K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation Jul 17, 2024 |
| K240845 — Rayvolve | Azmed Sas Jul 17, 2024 |
| K240503 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Jul 17, 2024 |
| K240609 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Jul 17, 2024 |
| K241467 — Stable-C Interbody System | Nexus Spine, LLC Jul 17, 2024 |
| K241121 — MICSI-RMT | Microstructure Imaging, Inc. Jul 17, 2024 |
| K241413 — sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC Jul 17, 2024 |
| K240705 — Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation Jul 17, 2024 |
| K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. Jul 17, 2024 |
| K241441 — RadiForce RX670; RadiForce RX670-AR | Eizo Corporation Jul 16, 2024 |
| K241050 — CrossRoads Modular Tray System | Crossroads Extremity Systems Jul 16, 2024 |
| K241741 — SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. Jul 16, 2024 |
| DEN230061 — allay Nerve Cap | Tulavi Therapeutics Jul 16, 2024 |
| K240272 — Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. Jul 16, 2024 |
| K241056 — Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. Jul 16, 2024 |
| K241740 — Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics Jul 16, 2024 |
| K240944 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Jul 16, 2024 |
| K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. Jul 16, 2024 |
| DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | Diasorin Molecular, LLC Jul 15, 2024 |
| K241739 — Endoscopic Applicator, 41 cm | Micromedics, Inc. Jul 15, 2024 |