| K230066 — Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. Sep 15, 2023 |
| K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | Zhenjiang Assure Medical Equipment Co., Ltd. Sep 15, 2023 |
| K220735 — Avologi Gel Primer (Model: Av25) | Premier North America, Inc. Sep 15, 2023 |
| K223857 — i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Sep 15, 2023 |
| K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. Sep 15, 2023 |
| K230526 — TEA Device | Transtimulation Research, Inc. Sep 14, 2023 |
| K231079 — LW Retraction Cap | Ossvis Co., Ltd. Sep 14, 2023 |
| K230237 — Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. Sep 14, 2023 |
| K230987 — FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG Sep 14, 2023 |
| K232827 — LightForce Orthodontic System | Lightforce Orthodontics Sep 14, 2023 |
| K231484 — PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. Sep 14, 2023 |
| K230959 — VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC Sep 14, 2023 |
| K231147 — Hammerdesis Interphalangeal Fusion System | Intelivation Sep 14, 2023 |
| K220034 — NEUROShield | In-Med Prognostics L3C Sep 14, 2023 |
| K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC Sep 14, 2023 |
| K230108 — Straumann® BLC and TLC Implants | Institut Straumann AG Sep 14, 2023 |
| K230167 — BACK 4 | Swims America Corp Sep 14, 2023 |
| K230775 — SOFIA EX Intracranial Support Catheter | MicroVention, Inc. Sep 14, 2023 |
| K231030 — Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation Sep 14, 2023 |
| K230746 — Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. Sep 14, 2023 |
| K232146 — Anovo Pedestal | Momentis Surgical , Ltd. Sep 14, 2023 |
| K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. Sep 14, 2023 |
| K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation Sep 14, 2023 |
| K231576 — cNeuro cPET | Combinostics OY Sep 14, 2023 |
| K232189 — OrionXR | Hoth Intelligence, Inc. Sep 14, 2023 |
| K231353 — AccuCTP Pro | ArteryFlow Technology Co., Ltd. Sep 14, 2023 |
| K232462 — ThermPix Thermovisual Camera | Usa Therm, Inc. Sep 14, 2023 |
| K232124 — IPL Hair Removal, Model: W-1095, W-1098 | Shenzhen Wochuan Electronic Co., Ltd. Sep 14, 2023 |
| K232487 — Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE Sep 14, 2023 |
| K223885 — HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. Sep 14, 2023 |
| DEN230021 — ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical Sep 13, 2023 |
| K221640 — AlloMap Heart Molecular Expression Testing | Caredx, Inc. Sep 13, 2023 |
| K230735 — Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. Sep 13, 2023 |
| K232485 — AMSCO 600 Steam Sterilizer | Steris Sep 13, 2023 |
| K230609 — NG Delivery Catheter | Balt USA, LLC Sep 13, 2023 |
| K223811 — Lung-CAD | Imagen Technologies, Inc. Sep 13, 2023 |
| K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. Sep 13, 2023 |
| K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. Sep 13, 2023 |
| K232158 — GenX-CR | Genoray Co., Ltd. Sep 13, 2023 |
| K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. Sep 12, 2023 |
| K230598 — Stone Extraction Baskets | Jiangsu Vedkang Medical Science And Technology Co., Ltd. Sep 12, 2023 |
| K213767 — Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. Sep 12, 2023 |
| K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation Sep 12, 2023 |
| K231112 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Sep 12, 2023 |
| K232459 — Velacur | Sonic Incytes Sep 12, 2023 |
| K231766 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) Sep 12, 2023 |
| K231892 — Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. Sep 12, 2023 |
| K231748 — Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation Sep 12, 2023 |
| K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG Sep 12, 2023 |
| K222938 — Ablation-fit | R.A.W. S.R.L Sep 12, 2023 |