| K231496 — TITAN 3-D Wedge System | Paragon 28, Inc. Aug 22, 2023 |
| K230899 — qXR-PTX-PE | Qure.Ai Technologies Aug 22, 2023 |
| K220938 — Nova HD+ | Aura Wellness, LLC Aug 22, 2023 |
| K231731 — Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | Mcgovern Medical School Aug 21, 2023 |
| K232185 — SM-IV | Sedecal., Sa. Aug 21, 2023 |
| K223813 — Aveta System 2.0 | Meditrina, Inc. Aug 21, 2023 |
| K230486 — Cove Strip | SeaSpine Orthopedics Corporation Aug 21, 2023 |
| K231763 — Stable-C Interbody System | Nexus Spine, LLC Aug 21, 2023 |
| K231867 — Grappler Suture Anchor System | Paragon 28, Inc. Aug 21, 2023 |
| K222245 — ACR Screw System | Biomaterials Korea, Inc. Aug 21, 2023 |
| K223560 — Plato 17 Microcatheter | Scientia Vascular, Inc. Aug 21, 2023 |
| K231266 — Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. Aug 21, 2023 |
| K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp Aug 19, 2023 |
| K223539 — Dreem 3S | Beacon Biosignals, Inc. Aug 18, 2023 |
| K223883 — Daye Tampon | Annes Daye, Ltd. Aug 18, 2023 |
| K232144 — Sterile Products of the APTUS System | Medartis AG Aug 18, 2023 |
| K231257 — Pangea Utility Plating System, Pangea Platform | Stryker GmbH Aug 18, 2023 |
| K231457 — SPARK Scan | Spark Neuro, Inc. Aug 18, 2023 |
| K231204 — Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App | Cochlear Aug 18, 2023 |
| K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. Aug 18, 2023 |
| K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | Shenzhen Beacon Display Technology Co., Ltd. Aug 18, 2023 |
| K231085 — 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. Aug 18, 2023 |
| K220253 — Eco Abutment, Multiunit Abutment | Dio Corporation Aug 18, 2023 |
| K230579 — Smart Wedge algorithm | Edwards Lifesciences, LLC Aug 18, 2023 |
| K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Stryker GmbH Aug 18, 2023 |
| K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Olympus Winter & Ibe GmbH Aug 18, 2023 |
| DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Boston Scientific Corporation Aug 18, 2023 |
| K231718 — Holmium Medical Laser | Allengers Global Healthcare Private Limited Aug 18, 2023 |
| K232150 — ZSFab Cervical Interbody System | Zsfab, Inc. Aug 18, 2023 |
| K231053 — Unicare (K-UNICARE-USA) | Tenscare, Ltd. Aug 18, 2023 |
| K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. Aug 18, 2023 |
| K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Smith & Nephew Medical Limited Aug 18, 2023 |
| K223867 — IDS ACTH II | Immunodiagnostic Systems Limited Aug 18, 2023 |
| K232153 — Avéli | Revelle Aesthetics, Inc. Aug 18, 2023 |
| K231673 — P200TE (A10700) | Optos Plc. Aug 18, 2023 |
| K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd Aug 18, 2023 |
| K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Corporation Aug 18, 2023 |
| K223163 — Sleepiz One+ | Sleepiz AG Aug 18, 2023 |
| K223573 — Onera Sleep Test System (Onera STS) | Onera B.V. Aug 18, 2023 |
| K230415 — Cadwell Guardian | Cadwell Industries, Inc. Aug 17, 2023 |
| K230690 — Tandry Locking Plate System | Microware Precision Co., Ltd. Aug 17, 2023 |
| K223167 — Spirair Nasal Septal Strap | Spirair, Inc. Aug 17, 2023 |
| K230871 — EXTRON 5; EXTRON 7 | DRTECH Corporation Aug 17, 2023 |
| K222773 — Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. Aug 17, 2023 |
| K222772 — Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. Aug 17, 2023 |
| K231481 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® Aug 17, 2023 |
| K230588 — Aer-O-Scope Colonoscope System | Gi View , Ltd. Aug 17, 2023 |
| K223912 — InterCollagen® Guide | Sigmagraft, Inc. Aug 17, 2023 |
| K223538 — Integrity Implant | Anika Therapeutics, Inc. Aug 17, 2023 |
| K230832 — Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries Aug 16, 2023 |