| URIS Smart Path Implant System & Prosthetic (K230438) | Truabutment, Inc. | 2023-12-29 |
| ACL TOP 970 CL (K233790) | Instrumentation Laboratory | 2023-12-29 |
| UniFit Dental Implant System (K223714) | Adin Dental Implant Systems , Ltd. | 2023-12-29 |
| Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (K233362) | Pelvital USA, Inc. | 2023-12-29 |
| Bladder Scanner (K230986) | Avantsonic Technology Co., Ltd. | 2023-12-29 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |
| NQ TMS for MDD (NQv1-MU-01) (K232688) | Neuroqore, Inc. | 2023-12-29 |
| Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim (K233405) | Eco Medi Glove Sdn. Bhd. | 2023-12-28 |
| Ankyras (K230006) | Mentice Spain S.L. | 2023-12-28 |
| x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) (K231055) | De Götzen S.R.L. | 2023-12-28 |
| Planmeca Viso (K230985) | Planmeca Oy | 2023-12-28 |
| EvoWalk 1.0 System (K230997) | Evolution Devices, Inc. | 2023-12-28 |
| SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant (K230891) | Healthium Medtech Limited | 2023-12-28 |
| Nurochek-II System (K231914) | Headsafe Mfg Pty, Ltd. | 2023-12-27 |
| EndoSound Vision System; EVS (K232518) | Endosound, Inc. | 2023-12-27 |
| Colibrí (K232756) | Copan Wasp Srl | 2023-12-27 |
| TriSalus TriGuideTM Guiding Catheter (K233858) | Trisalus Life Sciences | 2023-12-27 |
| TearCare MGX System (K231084) | Sight Sciences, Inc. | 2023-12-27 |
| Suture Wing (K233659) | Osteonic Co., Ltd. | 2023-12-26 |
| BTL-899M (K232937) | BTL Industries, Inc. | 2023-12-26 |
| Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K233515) | Nuwellis, Inc. | 2023-12-26 |
| POWEReam 1/4 Drive (K233300) | Stryker Instruments | 2023-12-26 |
| TumorSight Viz (K231130) | SimBioSys, Inc. | 2023-12-26 |
| Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 (K232338) | Alicn Medical Shenzhen, Inc. | 2023-12-22 |
| WellCare Anoscope (K230439) | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 |
| Interson USB Ultrasound System (K233734) | Interson Corporation | 2023-12-22 |
| Elegant™ Advanced CompHort (K231794) | Viramal Limited | 2023-12-22 |
| Distal Access Catheter (K233205) | Shanghai Heartcare Medical Technology Co., Ltd. | 2023-12-22 |
| Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (K232717) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 |
| VivaChek Link Plus Blood Glucose Monitoring System (K233058) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (K232881) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 |
| TP Pivot Pro™ Needle Guide (K233109) | Civco Medical Solutions | 2023-12-22 |
| Omnimax S3, Omnimax S4 (K233304) | Sharplight Technologies, Ltd. | 2023-12-22 |
| VIO System (V-1000) (K232789) | Enspectra Health, Inc. | 2023-12-22 |
| ART-Plan (K232479) | Therapanacea | 2023-12-22 |
| NeuMoDx CT/NG Assay 2.0 (K230267) | Neumodx Molecular, Inc. | 2023-12-22 |
| CPM System (K231086) | Analog Devices, Inc. | 2023-12-22 |
| MAGNETOM Sola; MAGNETOM Altea (K232535) | Siemens Medical Solutions USA, Inc. | 2023-12-22 |
| CloudTMS Edge for OCD (K233742) | Teleemg, LLC | 2023-12-22 |
| Novae® Dual Mobility System, Hype® Hip System (K223745) | Serf | 2023-12-22 |
| BioTraceIO Lite (DEN230020) | Techsomed Medical Technologies , Ltd. | 2023-12-22 |
| NanoZoomer S360MD Slide scanner system (K233027) | Hamamatsu Photonics K.K. | 2023-12-22 |
| TopCEM Dual Cure Resin Cement (K233082) | Rizhao Huge Biomaterials Company, Ltd. | 2023-12-22 |
| 3M™ Transbond™ Orthodontic Adhesive (K234043) | 3M Unitek Orthodontic Products | 2023-12-22 |
| qXR-LN (K231805) | Qure.Ai Technologies | 2023-12-22 |
| kallisio stentra™ oral stent (K232293) | Kallisio, Inc. | 2023-12-22 |
| Anthogyr INTEGRAL Guided Surgery Cassettes (K233264) | Anthogyr | 2023-12-22 |
| SofWave System (K233104) | Sofwave Medical, Ltd. | 2023-12-22 |
| ElastiMed SACS (K232300) | Elastimed , Ltd. | 2023-12-22 |
| RadiForce MX317W (K233465) | Eizo Corporation | 2023-12-21 |
| Hoffmann LRF System (K233741) | Stryker GmbH | 2023-12-21 |
| Disposable Laryngeal Electrodes (K232888) | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 |
| Reusable Blood Pressure Cuff (K233276) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023-12-21 |
| syngo Virtual Cockpit (VB10A) (K232744) | Siemens Healthcare GmbH | 2023-12-21 |
| Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (K233423) | Tyber Medical, LLC | 2023-12-21 |
| Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (K233848) | Gynesonics, Inc. | 2023-12-21 |
| Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) (K231889) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 |
| Bearing nsPVA Express™ (K233813) | Merit Medical Systems, Inc. | 2023-12-21 |
| LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (K223359) | Huizhou Foryou Medical Devices Co., Ltd. | 2023-12-21 |
| Elos Accurate Customized Abutment (K231307) | Elos Medtech Pinol A/S | 2023-12-21 |
| KaiBiLi Extended ViralTrans (K231027) | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 2023-12-21 |
| CALLISTO eye (K232944) | Carl Zeiss Meditec, AG | 2023-12-21 |
| Stryker Orthopaedics Hip Systems Labeling Update (K233498) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 |
| Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (K230887) | Sysmex America, Inc. | 2023-12-21 |
| Dental Glass Ceramics (K233016) | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2023-12-21 |
| Kangbeier Child Surgical Mask (K221753) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| Pediarity™ (K231531) | Hinlab, Inc. | 2023-12-21 |
| Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (K232329) | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 |
| SMR Hybrid Glenoid System (K231099) | Lima Corporate S.P.A. | 2023-12-21 |
| RELiZORB® (K232784) | Alcresta Therapeutics, Inc. | 2023-12-21 |
| SkyOPS™ Orthopedic Plate System (K233154) | Sky Surgical, LLC | 2023-12-21 |
| TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) (K232870) | Varian Medical Systems, Inc. | 2023-12-21 |
| Twoplus Applicator (K232579) | Hannah Life Technologies Pte , Ltd. | 2023-12-21 |
| HM70 EVO Diagnostic Ultrasound System (K233112) | Samsung Medison Co., Ltd. | 2023-12-21 |
| iSR`obot Mona Lisa 2.0 (K232320) | Biobot Surgical Pte., Ltd. | 2023-12-21 |
| FLOWpresso (K223729) | Medella Health Limited | 2023-12-21 |
| PICOSECOND Nd:YAG Laser System (K233018) | Ids, Ltd. | 2023-12-21 |
| Cannulated Screw System (K233396) | Smith & Nephew, Inc. | 2023-12-21 |
| Inessa System (K230545) | Triple Jump Israel , Ltd. | 2023-12-20 |
| MagnetOs Putty (K230736) | Kuros Biosciences B.V | 2023-12-20 |
| ARK Methotrexate II Assay (K232017) | Ark Diagnostics, Inc. | 2023-12-20 |
| SPECTRUM® GV Bone Cement (K231556) | Osteoremedies, LLC | 2023-12-20 |
| BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (K230855) | Becton, Dickinson and Company | 2023-12-20 |
| Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test (K232736) | Chemtron Biotech, Inc. | 2023-12-20 |
| INNO SLA Submerged Hybrid Ti-Base System (K231411) | Cowellmedi Co., Ltd. | 2023-12-20 |
| Perifit Care+ (K231780) | X6 Innovations | 2023-12-20 |
| Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (K232444) | Grand Work Plastic Products Co., Ltd. | 2023-12-20 |
| Digital image scanner of dental (K231660) | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023-12-20 |
| Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system (K233839) | Gbs Commonwealth Co., Ltd. | 2023-12-20 |
| uOmnispace.MI (K233176) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 |
| United Orthopedic Knee Patient Specific Instrumentation (K230850) | Enhatch, Inc. | 2023-12-20 |
| Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286) | Quidel Corporation | 2023-12-20 |
| syngo Application Software (K230955) | Siemens Medical Solutions USA, Inc. | 2023-12-20 |
| SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (K231227) | Baylis Medical Company, Inc. | 2023-12-20 |
| Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (K223585) | Yung Sheng Optical Co., Ltd. | 2023-12-20 |
| 10THERMA (K232992) | Tentech, Inc. | 2023-12-20 |
| Pocket Ultrasound System (C10) (K231354) | Beijing Konted Medical Technology Co.,Ltd | 2023-12-20 |
| SmoothSkin Pure Adapt (SSG3) (K233782) | Cyden Limited | 2023-12-20 |
| HP PTA Balloon Dilatation Catheter (K231402) | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 |
| Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (K232048) | Icu Medical | 2023-12-20 |