| K241810 — MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. Aug 15, 2024 |
| K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. Aug 15, 2024 |
| K240957 — Catapult Guide Sheath | Contract Medical International, GmbH Aug 14, 2024 |
| K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. Aug 14, 2024 |
| K241571 — BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight Aug 14, 2024 |
| K242077 — PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. Aug 14, 2024 |
| K232836 — Family of DIMAR DMAX NIV masks | Dimar S.P.A. Aug 14, 2024 |
| K241510 — CROSSLEAD Tracker | Asahi Intecc Co., Ltd. Aug 14, 2024 |
| K242059 — Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company Aug 14, 2024 |
| K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. Aug 14, 2024 |
| K240595 — Utepreva Endometrial Sampler (UP01) | Utepreva, LLC Aug 14, 2024 |
| K240713 — TRAUMAGEL® | Cresilon, Inc. Aug 14, 2024 |
| K241748 — Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose Aug 14, 2024 |
| K241094 — Bullsai | Turing Medical Technologies, Inc. Aug 13, 2024 |
| K241387 — CoLink NeoFuse MIS Plating System (see attached parts list) | In2Bones USA Aug 13, 2024 |
| K241699 — SUPER VELOCE | Ilooda Co,., Ltd. Aug 13, 2024 |
| K241686 — Power wheelchair (N6101) | Zhejiang Zhonglei Medical Technology Co. , Ltd. Aug 13, 2024 |
| K241429 — ECHELON Synergy MRI System | Fujifilm Healthcare Corporation Aug 13, 2024 |
| K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC Aug 13, 2024 |
| K241547 — Diode Laser Therapy Device (DF-DIODE LASER-S1) | Weifang Dragonfly Electronics Technology Co., Ltd. Aug 13, 2024 |
| K241978 — Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. Aug 13, 2024 |
| K240807 — VM-2000 | Ventis Medical, Inc. Aug 13, 2024 |
| K241846 — E3D-C Interbody System | Evolution Spine Aug 12, 2024 |
| K242054 — OptimMRI (v2) | Rebrain, Sas Aug 12, 2024 |
| K241402 — Medical Monitor (32HR734S) | Lg Electronics.Inc Aug 12, 2024 |
| K233367 — iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. Aug 12, 2024 |
| K241656 — Eneka Selectif | Termosalud Aug 12, 2024 |
| K241365 — Pixie Pulse (SM9068) | Pixie Cup, LLC Aug 12, 2024 |
| K240868 — Ultravision2 IonPencil | Alesi Surgical Limited Aug 12, 2024 |
| K242096 — dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. Aug 12, 2024 |
| DEN210037 — SoClean 3+ Bacterial Reduction Device | Soclean, Inc. Aug 12, 2024 |
| K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. Aug 12, 2024 |
| K241376 — HyperSuture All Blue Extension Line | Threadstone, LLC Aug 9, 2024 |
| K231950 — MEDIDIODE | Medicreations, LLC Aug 9, 2024 |
| K240079 — Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) | Suzhou Ideal Medical Co., Ltd. Aug 9, 2024 |
| K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC Aug 9, 2024 |
| K233697 — SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. Aug 9, 2024 |
| K222688 — The Trust | Genoss Co., Ltd. Aug 9, 2024 |
| K233643 — F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. Aug 9, 2024 |
| K234053 — F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. Aug 9, 2024 |
| K242016 — EnSite X EP System | ABBOTT MEDICAL Aug 9, 2024 |
| K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A Aug 9, 2024 |
| K240469 — Access TPO Antibody | Beckman Coulter, Inc. Aug 9, 2024 |
| K233720 — Luminopia | Luminopia, Inc. Aug 8, 2024 |
| K233822 — i2Contour | Mrimath, LLC Aug 8, 2024 |
| K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | Aktormed GmbH Aug 8, 2024 |
| K233702 — SMARxT Tubing and Connectors | LivaNova USA, Inc. Aug 8, 2024 |
| K241665 — Omni Legend | Ge Medical Systems Israel, Functional Imaging Aug 8, 2024 |
| K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. Aug 8, 2024 |
| K233356 — Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. Aug 8, 2024 |