| K231106 — Accuject Refra Injector AR2900 | Medicel AG Sep 19, 2023 |
| K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation Sep 19, 2023 |
| K221309 — AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. Sep 19, 2023 |
| K232544 — Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. Sep 18, 2023 |
| K231663 — The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. Sep 18, 2023 |
| K231367 — Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. Sep 18, 2023 |
| K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC Sep 18, 2023 |
| K232513 — X-Twist Biocomposite Suture Anchor | Parcus Medical Sep 18, 2023 |
| K223835 — MA-40, MA-112 | Medify Air, LLC Sep 18, 2023 |
| K222251 — B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | B.R.A.H.M.S GmbH, Part Of Thermo Fisher Sep 18, 2023 |
| K232172 — BTL-785BNF Handpiece | BTL Industries, Inc. Sep 18, 2023 |
| K231832 — Access Myoglobin | Beckman Coulter, Inc. Sep 18, 2023 |
| K231688 — ImPACT Version 4 | Impact Applications, Inc. Sep 16, 2023 |
| K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. Sep 16, 2023 |
| K222610 — Elecsys Anti-Tg | Roche Diagnostics Sep 15, 2023 |
| K232315 — Catalyst Bone Void Filler | Ossdsign AB Sep 15, 2023 |
| K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC Sep 15, 2023 |
| K223812 — Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. Sep 15, 2023 |
| K231336 — T2 Biothreat Panel | T2Biosystems, Inc. Sep 15, 2023 |
| K230946 — Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical Sep 15, 2023 |
| K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation Sep 15, 2023 |
| K232102 — ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. Sep 15, 2023 |
| K232121 — Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co., Ltd. Sep 15, 2023 |
| K230332 — Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S Sep 15, 2023 |
| K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. Sep 15, 2023 |
| K231235 — LW UCLA Abutment | Ossvis Co., Ltd. Sep 15, 2023 |
| K232508 — Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC Sep 15, 2023 |
| K220972 — Access Thyroglobulin | Beckman Coulter, Inc. Sep 15, 2023 |
| K231791 — PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. Sep 15, 2023 |
| K231242 — Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. Sep 15, 2023 |
| K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. Sep 15, 2023 |
| K230974 — NIDO Pedicle Screw System | Kalitec Medical Sep 15, 2023 |
| 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 |