| K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Oct 27, 2023 |
| K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. Oct 27, 2023 |
| K220493 — Plaxpot Multi Plasma | Gcs Co. Limited Oct 27, 2023 |
| K231934 — GIA Stapler with Tri-Staple Technology | Covidien Oct 27, 2023 |
| K232045 — MeVis Liver Suite | MeVis Medical Solutions AG Oct 27, 2023 |
| K232393 — BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Proedge Dental Products, Inc. Oct 27, 2023 |
| K232348 — RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC Oct 27, 2023 |
| K213146 — Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen | Jiangsu Rongye Technology Co., Ltd. Oct 27, 2023 |
| K231545 — hearOAE | Hearx SA (Pty) , Ltd. Oct 27, 2023 |
| K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) | Senorx, Inc. Oct 27, 2023 |
| K230826 — Modius Sleep | Neurovalens , Ltd. Oct 27, 2023 |
| K223541 — Cold/Hot Compression | Jkh Health Co., Ltd. Oct 27, 2023 |
| K231494 — CoreLink Robotic Navigation Instruments | Corelink, LLC Oct 27, 2023 |
| K233090 — DEKA AGAIN PRO family | El.En S.P.A. Oct 27, 2023 |
| K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. Oct 27, 2023 |
| K233241 — SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical Oct 27, 2023 |
| K230854 — SwiftMR | Airs Medical, Inc. Oct 27, 2023 |
| K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Oct 27, 2023 |
| K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. Oct 27, 2023 |
| K231761 — PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited Oct 27, 2023 |
| K231908 — 45 Micron Polyisoprene Condom | Suretex Limited Oct 27, 2023 |
| K231165 — Shina Syringe; Shina Safety Syringe | Shina Med Corporation Oct 27, 2023 |
| K232667 — OR3O Dual Mobility Liners | Smith & Nephew, Inc. Oct 27, 2023 |
| K232346 — Digital Expert Access with Remote Scanning | GE Healthcare Oct 27, 2023 |
| K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH Oct 27, 2023 |
| K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris Oct 27, 2023 |
| K232618 — Aurora Surgiscope System | Rebound Therapeutics Corporation Oct 27, 2023 |
| K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation Oct 27, 2023 |
| K233234 — PressON Spinal Fixation System | Nexus Spine, LLC Oct 26, 2023 |
| K232500 — Lumify Diagnostic Ultrasound System | Philips Ultrasound Oct 26, 2023 |
| K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. Oct 26, 2023 |
| K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. Oct 26, 2023 |
| K231595 — Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. Oct 26, 2023 |
| K213473 — Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. Oct 26, 2023 |
| K231579 — MOLLI 2 | Molli Surgical, Inc. Oct 26, 2023 |
| K232271 — SIMDA abutment | Simda Co., Ltd. Oct 26, 2023 |
| K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L Oct 26, 2023 |
| K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. Oct 26, 2023 |
| K233223 — OGmend® Implant Enhancement System | Woven Orthopedic Technologies Oct 26, 2023 |
| K230662 — Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co., Ltd. Oct 26, 2023 |
| K231737 — ANAX 5.5 Spinal System | Innosys Co., Ltd. Oct 26, 2023 |
| K231685 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 26, 2023 |
| K233101 — Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. Oct 26, 2023 |
| K230500 — Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | Jiangsu Maxf Electric Appliance Co., Ltd. Oct 26, 2023 |
| K231550 — Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC Oct 26, 2023 |
| K233417 — AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. Oct 26, 2023 |
| K231327 — POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. Oct 25, 2023 |
| K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation Oct 25, 2023 |
| K230284 — Penumbra LP Coil System | Penumbra, Inc. Oct 25, 2023 |
| K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. Oct 25, 2023 |