| K231150 — Cardio P1 | Bionet Co., Ltd. Nov 9, 2023 |
| K231804 — PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific Nov 9, 2023 |
| K231752 — ARK Hydrocodone Assay | Ark Diagnostics, Inc. Nov 9, 2023 |
| K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt. , Ltd. Nov 9, 2023 |
| K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. Nov 9, 2023 |
| K231798 — da Vinci SP Surgical System | Intuitive Surgical, Inc. Nov 8, 2023 |
| K223739 — VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. Nov 8, 2023 |
| K232152 — NerivioInfinity | Theranica Bioelectronics , Ltd. Nov 8, 2023 |
| DEN220091 — Dream Sock | Owlet Babycare, Inc. Nov 8, 2023 |
| K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L Nov 8, 2023 |
| K231765 — Contour ProtégéAI | Mim Software, Inc. Nov 8, 2023 |
| K230534 — BriefCase-Quantification | Aidoc Medical , Ltd. Nov 8, 2023 |
| K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited Nov 8, 2023 |
| K230400 — Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. Nov 8, 2023 |
| K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) | Jiangsu Channel Medical Device Co., Ltd. Nov 7, 2023 |
| K231966 — LOGIQ E10 | GE Medical Systems Ultrasound And Primary Care Diagnostics Nov 7, 2023 |
| K232292 — Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. Nov 7, 2023 |
| K231155 — Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. Nov 7, 2023 |
| 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 |