| K233447 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Jan 18, 2024 |
| K231860 — TDM Screw System | Tdm Co., Ltd. Jan 18, 2024 |
| K230592 — LuxCreo Dental Night Guard Resin | LuxCreo, Inc. Jan 18, 2024 |
| K231405 — Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. Jan 18, 2024 |
| K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax Of America, Inc. Jan 18, 2024 |
| K232577 — Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd Jan 18, 2024 |
| K234011 — AMF TT Cones | Lima Corporate S.P.A. Jan 18, 2024 |
| K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. Jan 18, 2024 |
| K221866 — S-Plant Dental Implant System | Newton Implant Systems, Inc. Jan 18, 2024 |
| K233213 — NxStage PureFlow Solution | Nxstage Medical, Inc. Jan 18, 2024 |
| K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC Jan 18, 2024 |
| K233077 — FlashHeal 2 (FlashHeal 2.0) | Inwound Aps Jan 18, 2024 |
| K233190 — ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd Jan 18, 2024 |
| K234040 — TriMed Threaded Intramedullary Nail System | TriMed, Inc. Jan 18, 2024 |
| K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | William Cook Europe Aps Jan 18, 2024 |
| K231573 — ThinkQA (Edition 2) | Dosisoft SA Jan 18, 2024 |
| K231762 — uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. Jan 18, 2024 |
| K232373 — Progrip Self-Gripping Polypropylene Mesh | Sofradim Production Jan 18, 2024 |
| K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. Jan 17, 2024 |
| K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Jan 17, 2024 |
| K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. Jan 17, 2024 |
| K233730 — Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew Jan 17, 2024 |
| K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation Jan 17, 2024 |
| K233226 — FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC Jan 17, 2024 |
| K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. Jan 17, 2024 |
| K233710 — Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. Jan 17, 2024 |
| K234030 — Clear Guide SCENERGY | Clear Guide Medical Jan 17, 2024 |
| K231135 — Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. Jan 17, 2024 |
| K231871 — Radify Triage | Envisionit Deepai, Ltd. Jan 17, 2024 |
| K223234 — Delta4 Insight | Scandidos AB Jan 16, 2024 |
| K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | SteriLance Medical (Suzhou), Inc. Jan 16, 2024 |
| K233970 — Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Jan 16, 2024 |
| K233512 — Rapid (6.0) | Ischemaview, Inc. Jan 16, 2024 |
| K233293 — Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. Jan 16, 2024 |
| K231138 — Aniti-Snore Mouthguard+ | Oscimed SA Jan 16, 2024 |
| K231144 — Washtrays | Dentsply Sirona Jan 16, 2024 |
| K232355 — Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. Jan 16, 2024 |
| K232062 — Uni-port | Dalim Medical Corp. Jan 16, 2024 |
| K223266 — Hilzo Esophageal Stents | Thoracent, Inc. Jan 16, 2024 |
| K233216 — CLEWICU System | Clew Medical , Ltd. Jan 13, 2024 |
| K232350 — Stryker Facial iD System | Stryker Craniomaxillofacial Jan 13, 2024 |
| K233155 — ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. Jan 12, 2024 |
| K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited Jan 12, 2024 |
| K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | Pentax Of America, Inc. Jan 12, 2024 |
| K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Anhui Powerguard Technology Co., Ltd. Jan 12, 2024 |
| K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC Jan 12, 2024 |
| K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. Jan 12, 2024 |
| K233355 — Cypris eXact Suturing System | Cypris Medical Jan 12, 2024 |
| K231371 — BEE Cervical Cage | NGMedical GmbH Jan 12, 2024 |
| K232970 — Hem-o-lok® Ligating Clips | Teleflex Medical Jan 12, 2024 |