| K223318 — Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc. May 10, 2023 |
| K223044 — Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. May 10, 2023 |
| K231032 — AMP by Method Mobility, AMP Plus (or +) by Method Mobility | Method Mobility May 10, 2023 |
| K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | Plasmapp Co,., Ltd. May 9, 2023 |
| K223825 — Tens & Ems Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. May 9, 2023 |
| K222436 — Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. May 9, 2023 |
| K223025 — Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. May 9, 2023 |
| K222484 — Retitrack | C. Light Technologies, Inc. May 9, 2023 |
| K212857 — Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | Jiangsu Zhiyu Medical Instrument Co, Ltd. May 9, 2023 |
| K223655 — Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. May 9, 2023 |
| K230721 — ATEC Lateral Plate System | Alphatec Spine, Inc. May 9, 2023 |
| K223335 — SIRION Lateral Lumbar Interbody System | Astura Medical May 9, 2023 |
| DEN220083 — Stanza | Swing Therapeutics, Inc. May 9, 2023 |
| K222719 — CX50N | Wide Corporation May 9, 2023 |
| K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. May 9, 2023 |
| K223280 — Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd May 8, 2023 |
| K222487 — Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. May 8, 2023 |
| K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | CC Wellness, LLC May 8, 2023 |
| K222716 — MX50N | Wide Corporation May 8, 2023 |
| K223428 — Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) | Shenzhen Leqing Medical Instrument Co., Ltd. May 8, 2023 |
| K230989 — Rod Registration Frame | Nu Vasive, Incorporated May 5, 2023 |
| K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. May 5, 2023 |
| K230616 — Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited May 5, 2023 |
| DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. May 5, 2023 |
| DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. May 5, 2023 |
| K222926 — Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | Shenzhen Yuezhongxing Technology Co., Ltd. May 5, 2023 |
| K223858 — Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. May 5, 2023 |
| K231017 — Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. May 5, 2023 |
| K202963 — ELEC Master, ELEC Master Dual | Mgnewton , Ltd. May 5, 2023 |
| K230615 — Electric Scooter (Model: S3312) | Guangdong Prestige Technology Co., Ltd. May 5, 2023 |
| K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. May 5, 2023 |
| K230351 — LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. May 5, 2023 |
| K230637 — Wattson temporary pacing guidewire (2250) | Vascular Solutions, LLC May 5, 2023 |
| K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | Bd Kiestra B.V. May 4, 2023 |
| K220713 — Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. May 4, 2023 |
| K221798 — Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. May 4, 2023 |
| K223756 — SimPro Now, GentleCath Hydrophilic | Dentsply Sirona May 4, 2023 |
| K222097 — OLYMPIC Deformity Band System | Astura Medical May 4, 2023 |
| K222388 — swiftPro System | Emblation , Ltd. May 4, 2023 |
| K230340 — Lucas Plus | Amt Engineering Co., Ltd. May 4, 2023 |
| K230082 — Auto Segmentation | Ge Medical Systems, LLC May 4, 2023 |
| K223430 — ProLift Micro Expandable Spacer System | Life Spine, Inc. May 4, 2023 |
| K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix , Ltd. May 4, 2023 |
| K230531 — SOZO Pro | ImpediMed Limited May 4, 2023 |
| K230994 — Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division May 4, 2023 |
| K230619 — Hubly Electric Drill (H100) | Hubly, Inc. May 4, 2023 |
| K220290 — Revitalair 430+ | Us Hyperbaric Network May 4, 2023 |
| K230653 — Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | Smith & Nephew, Inc. May 4, 2023 |
| K223771 — Lumify Diagnostic Ultrasound System | Philips Ultrasound May 4, 2023 |
| K230530 — SOZO Pro | ImpediMed Limited May 4, 2023 |