| K231629 — 091 Balloon Guide Catheter | Eosolutions, Corp. Oct 31, 2023 |
| K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. Oct 31, 2023 |
| K231362 — OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. Oct 31, 2023 |
| K232321 — FlexCath Contour Steerable Sheath | Medtronic, Inc. Oct 31, 2023 |
| K233320 — LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. Oct 31, 2023 |
| K231243 — Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. Oct 31, 2023 |
| K230328 — Speedboat Flush SB1 Instrument | Creo Medical, Ltd. Oct 31, 2023 |
| K232294 — HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One) | Edwards Lifesciences, LLC Oct 31, 2023 |
| K231868 — Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Shanghai Bangbang Robotics Co., Ltd. Oct 31, 2023 |
| K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. Oct 31, 2023 |
| K230083 — SAFIRA | Medovate Limited Oct 31, 2023 |
| K230602 — Hudson RCI® TurboMist Nebulizer System | Medline Industries, LP Oct 31, 2023 |
| K231947 — EVOLUTION® Cement Keel | Microport Orthopedics, Inc. Oct 31, 2023 |
| K232318 — VICTORY Lumbar Plate System | Globus Medical, Inc. Oct 31, 2023 |
| K232310 — Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific Oct 31, 2023 |
| K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. Oct 30, 2023 |
| K231340 — Renova Spine Balloon Catheter | Biopsybell S.R.L. Oct 30, 2023 |
| K231874 — AOT & T-L Abutment | Truabutment, Inc. Oct 30, 2023 |
| K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation Oct 30, 2023 |
| K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.R.L. Oct 30, 2023 |
| K230755 — NuEra Tight RF Model OptiStream | Bios S.R.L. Oct 30, 2023 |
| K231836 — ClariVy Cervical IBF System | Vy Spine, LLC Oct 30, 2023 |
| K232145 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Oct 30, 2023 |
| K231029 — Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | Zhonghong Pulin Medical Products Co., Ltd. Oct 30, 2023 |
| K231965 — Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 30, 2023 |
| K232751 — BriefCase-Triage | Aidoc Medical , Ltd. Oct 30, 2023 |
| K232280 — NextAR TSA Platform | Medacta International S.A. Oct 29, 2023 |
| K230418 — Mighty Wire Guide Wire | Merit Medical Systems, Inc. Oct 28, 2023 |
| K233270 — AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. Oct 28, 2023 |
| K231310 — Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. Oct 27, 2023 |
| K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Oct 27, 2023 |
| K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Oct 27, 2023 |
| 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 |