| K233420 — Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular Nov 7, 2023 |
| K231989 — LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound And Primary Care Diagnostic, Nov 7, 2023 |
| K232476 — Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. Nov 7, 2023 |
| K231470 — Lunit INSIGHT DBT | Lunit, Inc. Nov 6, 2023 |
| K231865 — Mouth Guard (ATG0603R) | Reazeal Corp Nov 6, 2023 |
| DEN220090 — EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Stemcell Technologies Canada, Inc. Nov 6, 2023 |
| K231519 — Revital Cady | Revital Healthcare (Epz) Limited Nov 6, 2023 |
| K232857 — KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG Nov 6, 2023 |
| K231316 — Aptima Trichomonas vaginalis Assay | Hologic, Inc. Nov 6, 2023 |
| K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Medartis AG Nov 3, 2023 |
| K231955 — aprevo® Digital Segmentation | Carlsmed, Inc. Nov 3, 2023 |
| K232742 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Nov 3, 2023 |
| K230078 — TRAX® CR Total Knee System | Amplitude Nov 3, 2023 |
| K230481 — Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. Nov 3, 2023 |
| K231586 — Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC Nov 3, 2023 |
| K233428 — Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd Nov 3, 2023 |
| K232382 — Control-IQ Technology | Tandem Diabetes Care, Inc. Nov 3, 2023 |
| K231918 — Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems Nov 3, 2023 |
| K232186 — LOGIQ e | Ge Medical Systems Ultrasound And Primary Care Diagnostic, Nov 3, 2023 |
| K230475 — Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. Nov 3, 2023 |
| K231254 — GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. Nov 3, 2023 |
| K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. Nov 3, 2023 |
| K231440 — Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. Nov 3, 2023 |
| K230343 — ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. Nov 3, 2023 |
| K230100 — SCIZER (SC1-M410) | Classys, Inc. Nov 3, 2023 |
| K232380 — t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. Nov 3, 2023 |
| K232113 — Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. Nov 3, 2023 |
| K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. Nov 3, 2023 |
| K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. Nov 3, 2023 |
| K233056 — EpiZact | Guidestar Medical Devices Nov 2, 2023 |
| K232345 — ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. Nov 2, 2023 |
| K230800 — XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | GEMSS HEALTHCARE CO., LTD. Nov 2, 2023 |
| K232029 — VersaWrap Nerve Protector | Alafair Biosciences, Inc. Nov 2, 2023 |
| K232532 — Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co., Ltd. Nov 2, 2023 |
| K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | AtriCure, Inc. Nov 2, 2023 |
| K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd. Nov 2, 2023 |
| K233518 — BASE290 LED Curing Light | Handpiece Headquarters Nov 2, 2023 |
| K232725 — Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. Nov 2, 2023 |
| K232076 — Fibercure | Lumendo AG Nov 2, 2023 |
| K230326 — ENFit to ENFit Extension Sets | Vesco Medical Nov 2, 2023 |
| K232176 — STELLAR Knee | Polarisar, Inc. Nov 2, 2023 |
| K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Nov 1, 2023 |
| K233502 — TERA HARZ II | Graphy, Inc. Nov 1, 2023 |
| K233402 — Bard 3DMax Mesh | Davol Inc., Subsidiary Of C. R. Bard, Inc. Nov 1, 2023 |
| K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. Nov 1, 2023 |
| K232730 — Aventus Thrombectomy System | Inquis Medical Nov 1, 2023 |
| K232880 — Inzii Ripstop Redeployable Retrieval System | Applied Medical Resources Corporation Nov 1, 2023 |
| K230814 — VRNT | Cognifisense, Inc. Oct 31, 2023 |
| K232099 — Neodent Implant System - GM Zygomatic Implant System | JJGC Indústria E Comércio De Materiais Dentários S.A. Oct 31, 2023 |
| K231238 — Ultravision2 System | Alesi Surgical, Ltd. Oct 31, 2023 |