| K241043 — Augment Off-Axis Instrument System | Fix Surgical May 15, 2024 |
| K241112 — BriefCase-Quantification | Aidoc Medical , Ltd. May 15, 2024 |
| K233985 — TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY May 15, 2024 |
| K240368 — E3D-A Interbody System | Evolution Spine May 15, 2024 |
| K240426 — Aventus Clot Management System | Inquis Medical May 14, 2024 |
| K233913 — Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) | Aoj Health Technology Co., Ltd. May 14, 2024 |
| K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics Nle May 14, 2024 |
| K232529 — Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. May 13, 2024 |
| K233875 — Brainomix 360 e-Lung | Brainomix Limited May 13, 2024 |
| K232242 — BEAR 2 Body | Foreo, Inc. May 13, 2024 |
| K232614 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | Sri Trang Gloves (Thailand) Public Company Limited May 13, 2024 |
| K232862 — MIM Monte Carlo Dosimetry | Mim Software, Inc. May 13, 2024 |
| K240759 — REMEX-GR100 | Remedi Co., Ltd. May 13, 2024 |
| K240658 — 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. May 13, 2024 |
| K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific,, LLC May 13, 2024 |
| K240479 — Access OV Monitor | Beckman Coulter, Inc. May 10, 2024 |
| K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. May 10, 2024 |
| K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC May 10, 2024 |
| K240365 — Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. May 10, 2024 |
| K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) May 10, 2024 |
| K233277 — Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. May 10, 2024 |
| K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. May 10, 2024 |
| K240699 — SCARLET® AC-Ti | Spineart SA May 10, 2024 |
| K234079 — HyperSuture Extension Line | Threadstone, LLC May 10, 2024 |
| K233100 — QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH May 10, 2024 |
| K232507 — Aerogen®Solo Nebulizer System | Aerogen, Ltd. May 10, 2024 |
| K232410 — SmartChest | Milvue May 10, 2024 |
| K233629 — APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation May 10, 2024 |
| K240374 — Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. May 10, 2024 |
| K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. May 10, 2024 |
| K232475 — Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. May 10, 2024 |
| K234112 — Customized Abutment | Arum Dentistry Co., Ltd. May 9, 2024 |
| K233967 — DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH May 9, 2024 |
| K232477 — Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) | Jiangxi AOV Maternity & Baby Products Co., Ltd. May 9, 2024 |
| K233918 — Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory May 9, 2024 |
| K240296 — Tulsa Pro System (Pad-105) | Profound Medical, Inc. May 9, 2024 |
| K232025 — Hushd Pro Avera | Good Sleep CO Pte , Ltd. May 9, 2024 |
| K232470 — Polyisoprene Extra Large Condom | Suretex Limited May 9, 2024 |
| K233418 — Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. May 9, 2024 |
| K233602 — P200TE (A10700) | Optos Plc. May 9, 2024 |
| K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. May 9, 2024 |
| K232976 — VUZE System | Vuze Medical , Ltd. May 9, 2024 |
| K233982 — CEREGLIDE 92 Catheter System | Cerenovus, Inc. May 9, 2024 |
| K232468 — SC Medica FFX | Sc Medica May 9, 2024 |
| K240403 — Access BR Monitor | Beckman Coulter, Inc. May 9, 2024 |
| K240964 — FLOW 90? Wand | ArthroCare Corporation May 8, 2024 |
| K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics May 8, 2024 |
| K241008 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) | Relign Corporation, Subsidiary Of Zimmer Biomet May 8, 2024 |
| K233803 — UltraClear Laser System (N/A) | Acclaro Corporation May 8, 2024 |
| K222292 — F&P myAirvo 3 | Fisher & Paykel Healthcare May 8, 2024 |