| K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Biokit, S.A. Sep 20, 2023 |
| K232582 — Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S Sep 20, 2023 |
| K232583 — Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. Sep 20, 2023 |
| K223179 — Cholestech LDX System | Alere San Diego, Inc. Sep 20, 2023 |
| K232592 — CITRELOCK® DUO | Acuitive Technologies, Inc. Sep 20, 2023 |
| K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC Sep 20, 2023 |
| K223913 — Socrates Aspiration System | Scientia Vascular, Inc. Sep 20, 2023 |
| K231894 — LED Spectrum therapy instrument | Shenzhenshi Sincoheren S&T Development Co., Ltd. Sep 20, 2023 |
| K231385 — Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. Sep 20, 2023 |
| K230011 — Mpact Extension | Medacta International S.A. Sep 20, 2023 |
| K231342 — Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. Sep 20, 2023 |
| K230239 — AirSeal iFS System; AirSeal dV Solution | Conmed Corporation Sep 20, 2023 |
| K230043 — Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Sep 20, 2023 |
| K223421 — MedCAD AccuPlan Orthopedics System | Medcad Sep 20, 2023 |
| K231281 — Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation Sep 19, 2023 |
| K230966 — angiOCCLUDE Ligating Clips | A2 Medical Systems, LLC Sep 19, 2023 |
| K222948 — Q Distal Access Catheter | Mivi Neuroscience, Inc. Sep 19, 2023 |
| K231802 — Millipede 088 Access Catheter | Perfuze, Ltd. Sep 19, 2023 |
| K231106 — Accuject Refra Injector AR2900 | Medicel AG Sep 19, 2023 |
| K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation Sep 19, 2023 |
| K221309 — AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. Sep 19, 2023 |
| K232544 — Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. Sep 18, 2023 |
| K231663 — The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. Sep 18, 2023 |
| K231367 — Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. Sep 18, 2023 |
| K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC Sep 18, 2023 |
| K232513 — X-Twist Biocomposite Suture Anchor | Parcus Medical Sep 18, 2023 |
| K223835 — MA-40, MA-112 | Medify Air, LLC Sep 18, 2023 |
| K222251 — B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | B.R.A.H.M.S GmbH, Part Of Thermo Fisher Sep 18, 2023 |
| K232172 — BTL-785BNF Handpiece | BTL Industries, Inc. Sep 18, 2023 |
| K231832 — Access Myoglobin | Beckman Coulter, Inc. Sep 18, 2023 |
| K231688 — ImPACT Version 4 | Impact Applications, Inc. Sep 16, 2023 |
| K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. Sep 16, 2023 |
| K222610 — Elecsys Anti-Tg | Roche Diagnostics Sep 15, 2023 |
| K232315 — Catalyst Bone Void Filler | Ossdsign AB Sep 15, 2023 |
| K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC Sep 15, 2023 |
| K223812 — Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. Sep 15, 2023 |
| K231336 — T2 Biothreat Panel | T2Biosystems, Inc. Sep 15, 2023 |
| K230946 — Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical Sep 15, 2023 |
| K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation Sep 15, 2023 |
| K232102 — ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. Sep 15, 2023 |
| K232121 — Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co., Ltd. Sep 15, 2023 |
| K230332 — Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S Sep 15, 2023 |
| K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. Sep 15, 2023 |
| K231235 — LW UCLA Abutment | Ossvis Co., Ltd. Sep 15, 2023 |
| K232508 — Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC Sep 15, 2023 |
| K220972 — Access Thyroglobulin | Beckman Coulter, Inc. Sep 15, 2023 |
| K231791 — PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. Sep 15, 2023 |
| K231242 — Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. Sep 15, 2023 |
| K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. Sep 15, 2023 |
| K230974 — NIDO Pedicle Screw System | Kalitec Medical Sep 15, 2023 |