| K230627 — Zilia Ocular FC (ZIL-10002) | Zilia, Inc. Nov 20, 2023 |
| K230700 — RIWOtrack Navigation System | Fiagon GmbH Nov 20, 2023 |
| K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | Hg Innovations, Ltd. Nov 20, 2023 |
| K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force | Hg Innovations, Ltd. Nov 20, 2023 |
| K231498 — TraumaCad Neo | Brainlab , Ltd. Nov 20, 2023 |
| K232555 — Harmony | Topcon Healthcare Solutions Nov 20, 2023 |
| K232512 — Masimo W1 | Masimo Corporation Nov 17, 2023 |
| K230954 — Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated Nov 17, 2023 |
| K232501 — AI Platform (AIP001) | Exo, Inc. Nov 17, 2023 |
| K232925 — Gastric Alimetry System | Alimetry , Ltd. Nov 17, 2023 |
| K231600 — SENDERO Microcatheter | Okami Medical, Inc. Nov 17, 2023 |
| K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited Nov 17, 2023 |
| K231559 — Multi-Unit DAS System | Talladium España, SL Nov 17, 2023 |
| K230190 — Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. Nov 17, 2023 |
| K231020 — Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation Nov 17, 2023 |
| K232974 — EKGenius Smart System | Ekgenius, LLC Nov 17, 2023 |
| K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | Wrp Asia Pacific Sdn. Bhd. Nov 17, 2023 |
| K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC Nov 17, 2023 |
| K230589 — Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. Nov 17, 2023 |
| K231652 — D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. Nov 16, 2023 |
| K231445 — LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG Nov 16, 2023 |
| K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Alcon Laboratories, Inc. Nov 16, 2023 |
| K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. Nov 16, 2023 |
| K230451 — Aptima® Chlamydia trachomatis Assay | Hologic, Inc. Nov 16, 2023 |
| K233302 — OSSIOfiber® Compression Staple | OSSIO , Ltd. Nov 16, 2023 |
| K231694 — MASADA Modular Spinal Fixation System | Astura Medical Nov 16, 2023 |
| K232521 — ExactechGPS® Total Ankle Application | Blue Ortho Nov 16, 2023 |
| K231738 — NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. Nov 16, 2023 |
| K233443 — Vital Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Nov 16, 2023 |
| K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | GEMSS HEALTHCARE CO., LTD. Nov 16, 2023 |
| K232392 — CT Lung Ventilation Analysis Software (CT:V) | 4Dmedical Limited Nov 16, 2023 |
| K232945 — Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (Dba MedComp) Nov 16, 2023 |
| K232533 — ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas Nov 16, 2023 |
| K232753 — EXPD 4343D; EXPD 3643D | DRTECH Corporation Nov 16, 2023 |
| K230463 — NSite Scoliosis Assessment App | Nsite, Inc. Nov 15, 2023 |
| K232841 — Axial3D Insight | Axial Medical Printing Limited Nov 15, 2023 |
| DEN200070 — Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) Nov 15, 2023 |
| K231012 — CoolSeal Trinity | Bolder Surgical, LLC Nov 15, 2023 |
| K231818 — METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. Nov 15, 2023 |
| K232973 — Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. Nov 15, 2023 |
| K223414 — Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. Nov 15, 2023 |
| K231852 — BinkieRT | Papricalab Nov 15, 2023 |
| K230856 — BrainSpec Core Software | Brainspec, Inc. Nov 14, 2023 |
| K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA Nov 14, 2023 |
| K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Prismatik Dentalcraft, Inc. Nov 14, 2023 |
| K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. Nov 14, 2023 |
| K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Prismatik Dentalcraft, Inc. Nov 14, 2023 |
| K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | Kossan International Sdn Bhd Nov 14, 2023 |
| K232656 — BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. Nov 14, 2023 |
| K231783 — VitroPRO | CIVCO Medical Instruments Co., Inc. Nov 14, 2023 |