| K241178 — DEKA ACE Pump System | Deka Research And Development May 24, 2024 |
| K231426 — 8plant Implant System | Hoowon Edi Co., Ltd. May 24, 2024 |
| K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated May 24, 2024 |
| K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. May 24, 2024 |
| K233285 — KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. May 24, 2024 |
| K233111 — ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | Foshan United Medical Technologies, Ltd. May 24, 2024 |
| K233089 — NeoSpan® Compression Implant System | In2Bones USA, LLC May 24, 2024 |
| K240864 — PacePro Wire | Opsens, Inc. May 24, 2024 |
| K232632 — Racz Neurostat RF Generator | Epimed International May 24, 2024 |
| K233386 — Monik - Disposable Endoscopic Trocar | M/S. Meril Endo Surgery Private Limited. May 24, 2024 |
| K240810 — Anti Grinding Guard | Xiamen Yizhou Imp. & Exp. Co., Ltd. May 24, 2024 |
| K240769 — LVivo IQS | Dia Imaging Analysis, Ltd. May 24, 2024 |
| K232788 — INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. May 24, 2024 |
| K234154 — uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. May 24, 2024 |
| K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical May 24, 2024 |
| K232639 — Apollo TMS Therapy System | Mag & More GmbH May 24, 2024 |
| K240827 — SET-5002 | Shimadzu Corporation Medical Systems Division May 24, 2024 |
| K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. May 23, 2024 |
| K241396 — uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. May 23, 2024 |
| K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation | Brainlab AG May 23, 2024 |
| K233108 — VinDr-Mammo | Vinbigdata Joint Stock Company May 23, 2024 |
| K232603 — CamAPS FX | Camdiab , Ltd. May 23, 2024 |
| K240294 — Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH May 23, 2024 |
| K233251 — NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. May 23, 2024 |
| K233868 — dima Print Teeth & Temp | Kulzer, LLC May 23, 2024 |
| K233120 — CWM-930S, FIXER DV9 | Chungwoo Co., Ltd. May 23, 2024 |
| K232642 — AirKEE T900 | Healkee Medical Pte, Ltd. May 23, 2024 |
| K232602 — 3DMatrix Surgical Mesh | Printbio, Inc. May 23, 2024 |
| K241014 — Biomet Kirschner Wires (K-Wires) | Biomet, Inc. May 22, 2024 |
| K232655 — Bonvadis® | Stemcyte, Inc. May 22, 2024 |
| K233884 — INUMI Flex Needle | Galvanize Therapeutics, Inc. May 22, 2024 |
| K240224 — Zenition 90 | Philips Medical Systems Nederlands B.V. May 22, 2024 |
| K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV May 22, 2024 |
| K233268 — Impress Angiographic Catheter | Merit Medical Systems, Inc. May 22, 2024 |
| K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. May 22, 2024 |
| K232740 — Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. May 22, 2024 |
| K240456 — Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC May 22, 2024 |
| K233099 — Gladiator | Rohrer Aesthetics, LLC May 22, 2024 |
| K241106 — Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., , Ltd. May 22, 2024 |
| K233819 — Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC May 22, 2024 |
| K240199 — IntraOp Alignment System | Alphatec Spine, Inc. May 22, 2024 |
| K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences May 22, 2024 |
| K241126 — OviTex PRS | TELA Bio, Inc. May 22, 2024 |
| K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. May 22, 2024 |
| K233442 — troCarWash System | Biotex, Inc. May 21, 2024 |
| K240433 — ProSeal Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. May 21, 2024 |
| K233543 — YSIO X.pree | Siemens Medical Solutions May 21, 2024 |
| K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | Centers For Disease Control And Prevention May 21, 2024 |
| K232946 — Yumizen H2500 | HORIBA ABX SAS May 21, 2024 |
| K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG May 21, 2024 |