| 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 |
| 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 |