| enspire 300 Series Automated Endoscope Reprocessor System (K230560) | STERIS Corporation | 2023-07-21 |
| BD Alaris System with Guardrails Suite MX v12.1.2 (K211218) | Carefusion 303, Inc. | 2023-07-21 |
| KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K231021) | Kimberly-Clark Corporation | 2023-07-21 |
| ROSA ONE Brain Application (K231103) | Medtech S.A.S | 2023-07-20 |
| Oxygen concentrator (K222920) | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023-07-20 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (K230875) | Central Medicare Sdn Bhd | 2023-07-20 |
| AccuCheck (K223834) | Manteia Technologies Co., Ltd. | 2023-07-20 |
| VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits (K231945) | AngioDynamics, Inc. | 2023-07-20 |
| Panther 5 (K213098) | Origin Medical Devices | 2023-07-20 |
| ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (K220977) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-07-20 |
| CROSSLEAD Penetration Peripheral Guide Wire (K230377) | Asahi Intecc Co., Ltd. | 2023-07-20 |
| IGAR System (1001.A) (K223484) | Insight Medbotics, Inc. | 2023-07-20 |
| uOmnispace (K230039) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-20 |
| CastleLoc-S Posterior Cervical Fixation System (K231840) | L&K BIOMED Co., Ltd. | 2023-07-20 |
| The InMode System with the Morpheus8 Applicators (K231790) | InMode , Ltd. | 2023-07-20 |
| INERTIA® CONNEXX™ Modular Pedicle Screw System (K231799) | Nexxt Spine, LLC | 2023-07-20 |
| QUASAR Standalone ACIF System (K231808) | GS Medical Co., Ltd. | 2023-07-20 |
| Oscar 15 & Oscar 15i (K230787) | Genoray Co., Ltd. | 2023-07-20 |
| ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System (K223301) | Spinecraft, LLC | 2023-07-20 |
| TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (K231292) | Bonebridge AG | 2023-07-19 |
| AXINON® LDL-p Test System (K210801) | Numares AG | 2023-07-19 |
| BACK 3 (K230037) | Swims America Corp | 2023-07-19 |
| TANDEM Hip System (K231448) | Smith & Nephew, Inc. | 2023-07-19 |
| Galen ES Cooperative Surgical Assistant Platform, Galen ES (DEN220047) | Galen Robotics | 2023-07-19 |
| RenaPure Endotoxin Retentive Filter (K231410) | Evoqua Water Technologies, LLC | 2023-07-19 |
| Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) (K231472) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2023-07-19 |
| LF900 (K231437) | Daesung Maref Co., Ltd. | 2023-07-19 |
| Grreen X 12 (Model: PHT-75CHS) (K231796) | VATECH Co., Ltd. | 2023-07-19 |
| CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (K231839) | L&K BIOMED Co., Ltd. | 2023-07-19 |
| Nu-beca Transcutaneous Electrical Nerve Stimulation (K223151) | Nu-Beca & Maxcellent Co. | 2023-07-19 |
| syngo.CT Lung CAD (Version VD30) (K231157) | Siemens Healthcare GmbH | 2023-07-19 |
| FMT Reusable Temperature Probes (K213100) | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | 2023-07-18 |
| TRUST (K221107) | Rgorithm Korea | 2023-07-18 |
| Forma Medical Headless Compression Screw (K230945) | Forma Medical, Inc. | 2023-07-18 |
| Bone Chamber Implant (K223339) | Megagen Implant Co., Ltd. | 2023-07-18 |
| Robotic Graft Delivery Instruments (K230716) | Medtronic Sofamor Danek, Inc. | 2023-07-18 |
| Hypodermic Syringes & Needle (K222925) | Lifelong Meditech Private Limited | 2023-07-18 |
| Avitus® DragonWing Large Volume Autograft Delivery System (K231456) | Avitus Orthopaedics, Inc. | 2023-07-17 |
| “POINT” Kinguide Agile Hybrid Navigation System (K230087) | Point Robotics MedTech, Inc. | 2023-07-17 |
| BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes (K213953) | Becton, Dickinson and Company | 2023-07-17 |
| Arthrex Intramedullary Nails (K230257) | Arthrex, Inc. | 2023-07-17 |
| iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (K230846) | Conformis, Inc. | 2023-07-17 |
| Revital-Ox PAA High Level Disinfectant Chemical Indicator (K230558) | STERIS Corporation | 2023-07-17 |
| LaserME (K230077) | Neauvia North America | 2023-07-17 |
| OPTIX H2 Patient Specific Instrument System (K230462) | Vilex, LLC | 2023-07-17 |
| TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (K223252) | Exactech, Inc. | 2023-07-17 |
| Pulse Oximeter (K211143) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2023-07-17 |
| Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) (K230395) | Durio Ppe Sdn Bhd | 2023-07-17 |
| ARIX Ankle System (K231441) | Jeil Medical Corporation | 2023-07-17 |
| FloNavi Open Field Fluorescence Imaging System (K230407) | Guangdong Optomedic Technologies, Inc. | 2023-07-17 |
| Fibroid Mapping Reviewer Application (FMRA) (K222683) | Nesa Medtech Private Limited | 2023-07-17 |
| FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (K231460) | K&J Consulting Corp. | 2023-07-16 |
| Mobility Scooter (Models: W3431D) (K231428) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-07-14 |
| Neodent Implant System - Zirconia Implant System (K222026) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-07-14 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| JiveX (Model Number / Release: 5.4) (K231041) | Visus Health IT GmbH | 2023-07-14 |
| PathLoc SI Joint Fusion System (K231841) | L&K BIOMED Co., Ltd. | 2023-07-14 |
| Bonafix TiBase (K221673) | Zentek Medical, LLC | 2023-07-14 |
| Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) (K223106) | Brainlab AG | 2023-07-14 |
| Ruthless Spine RJB (DEN230012) | Ruthless, LLC Dba Ruthless Spine | 2023-07-14 |
| Ultraflex™ Tracheobronchial Stent System (K230269) | Boston Scientific Corporation | 2023-07-14 |
| OnX Tough (K230445) | Sprintray, Inc. | 2023-07-14 |
| Cercare Medical Neurosuite (K230016) | Cercare Medical A/S | 2023-07-14 |
| FlowSaver Blood Return System (80-101) (K231782) | Inari Medical, Inc. | 2023-07-14 |
| CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) (K223290) | Sentiar, Inc. | 2023-07-14 |
| TalWire (K223791) | Embrace Medical , Ltd. | 2023-07-14 |
| Ez3D-i /E3 (K231757) | Ewoosoft Co., Ltd. | 2023-07-14 |
| NaviNetics Reusable Stereotactic System (NN1000) (K231392) | Navinetics, Inc. | 2023-07-14 |
| Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173) | W&H Dentalwerk Buermoss GmbH | 2023-07-14 |
| Wearable Breast Pump (Model S18) (K223886) | Shenzhen TPH Technology Co., Ltd. | 2023-07-14 |
| Micro Rx (K223728) | Imds Operations B.V. | 2023-07-13 |
| Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (K231438) | Alphatec Spine, Inc. | 2023-07-13 |
| ReddyPort Elbow (K231064) | Smd Manufacturing, LLC | 2023-07-13 |
| Portable X-ray System Model Ray98(P) (K231449) | Ningbo Runyes Medical Instrument Co., Ltd. | 2023-07-13 |
| ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit (K230863) | Zeus Scientific | 2023-07-13 |
| XR90 (XR90-SYS) (K223125) | Mediview Xr, Inc. | 2023-07-13 |
| Chondral Quant (K231351) | Siemens Medical Soultions USA, Inc. | 2023-07-13 |
| ECHELON Synergy MRI system (K223426) | Fujifilm Healthcare Corporation | 2023-07-13 |
| Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (K222116) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 |
| Spine Auto Views (K223424) | GE Medical Systems SCS | 2023-07-13 |
| X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (K230611) | Xstrahl, Ltd. | 2023-07-13 |
| HydroMARK Plus Breast Biopsy Site Marker (K221961) | Devicor Medical Products, Inc. | 2023-07-13 |
| Admira Fusion 5 (K230877) | Voco GmbH | 2023-07-13 |
| Praxiject™ 0.9% NaCl (K231754) | Medxl, Inc. | 2023-07-13 |
| activL® Next Generation Instrumentation (K231769) | Aesculap Implants Systems, LLC | 2023-07-13 |
| Biograph Vision.X and Biograph Vision.X Edge (K231833) | Siemens Medical Solutions USA, Inc. | 2023-07-13 |
| Open Rib (K223261) | Canon Medical Informatics, Inc. | 2023-07-13 |
| Zavation Navigation Instrument System (K223808) | Zavation Medical Products, LLC | 2023-07-12 |
| NanoHive Medical Lumbar Interbody System (K231241) | NanoHive Medical, LLC | 2023-07-12 |
| Graftys Quickset (K231714) | Graftys | 2023-07-12 |
| AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (K231709) | Radmedix, LLC | 2023-07-12 |
| AusculThing ACC (K230823) | Ausculthing OY | 2023-07-12 |
| RADx Intraoral Appliance for Snoring and Sleep Apnea (K230532) | Achaemenid, LLC | 2023-07-12 |
| FusedCO Algorithm (K231035) | Edwards Lifesciences, LLC | 2023-07-12 |
| Comprehensive Segmental Revision System(SRS) (K223631) | Biomet Orthopedics | 2023-07-12 |
| Dentis i-Clean System (K230307) | Dentis Co., Ltd. | 2023-07-11 |
| Play and Joy Water-Based Lubricant (K221137) | Innovemed Bio-Tech Co., Ltd. | 2023-07-11 |
| Bonalive Orthopedics granules (K231528) | Bonalive Biomaterials, Ltd. | 2023-07-11 |
| Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386) | Orthocon, Inc. | 2023-07-11 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K230427) | Integra LifeSciences Corporation | 2023-07-11 |