| Insulin Pen Needle (K230043) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 |
| 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (K231854) | Stryker | 2023-09-20 |
| Mpact Extension (K230011) | Medacta International S.A. | 2023-09-20 |
| AirSeal iFS System; AirSeal dV Solution (K230239) | Conmed Corporation | 2023-09-20 |
| MedCAD AccuPlan Orthopedics System (K223421) | Medcad | 2023-09-20 |
| TULSA-PRO System (K230692) | Profound Medical, Inc. | 2023-09-20 |
| Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K232582) | Ambu A/S | 2023-09-20 |
| Catalyst R1 Reverse Shoulder System (K232583) | Catalyst Orthoscience, Inc. | 2023-09-20 |
| Rology Teleradiology Platform (v.1.22.1103) (K231385) | Rology, Inc. | 2023-09-20 |
| ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987) | Biokit, S.A. | 2023-09-20 |
| DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System (K232556) | Depuy Ireland UC | 2023-09-20 |
| LED Spectrum therapy instrument (K231894) | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-09-20 |
| Socrates Aspiration System (K223913) | Scientia Vascular, Inc. | 2023-09-20 |
| CITRELOCK® DUO (K232592) | Acuitive Technologies, Inc. | 2023-09-20 |
| Millipede 088 Access Catheter (K231802) | Perfuze, Ltd. | 2023-09-19 |
| Q Distal Access Catheter (K222948) | Mivi Neuroscience, Inc. | 2023-09-19 |
| angiOCCLUDE Ligating Clips (K230966) | A2 Medical Systems, LLC | 2023-09-19 |
| Accuject Refra Injector AR2900 (K231106) | Medicel AG | 2023-09-19 |
| GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (K232178) | DRGEM Corporation | 2023-09-19 |
| AI100 with Shonit (K221309) | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 |
| Aquilion Serve (TSX-307A/1) V1.3 (K231281) | Canon Medical Systems Corporation | 2023-09-19 |
| The AVEOtsd (Tongue Stabilizing Device) Mouthpiece (K231663) | Innovative Health Technologies (Nz), Ltd. | 2023-09-18 |
| MA-40, MA-112 (K223835) | Medify Air, LLC | 2023-09-18 |
| Access Myoglobin (K231832) | Beckman Coulter, Inc. | 2023-09-18 |
| Apollo ESG NXT System, Apollo REVISE NXT System (K232544) | Apollo Endosurgery, Inc. | 2023-09-18 |
| X-Twist Biocomposite Suture Anchor (K232513) | Parcus Medical | 2023-09-18 |
| Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) (K231367) | Shenzhen Finicare Co., Ltd. | 2023-09-18 |
| Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (K232530) | Nexus Spine, LLC | 2023-09-18 |
| 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 (K222251) | B.R.A.H.M.S GmbH, Part of Thermo Fisher | 2023-09-18 |
| BTL-785BNF Handpiece (K232172) | BTL Industries, Inc. | 2023-09-18 |
| ImPACT Version 4 (K231688) | Impact Applications, Inc. | 2023-09-16 |
| Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (K230483) | Passy-Muir, Inc. | 2023-09-16 |
| The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788) | Medsource International, LLC | 2023-09-15 |
| ClearPoint Array System (Version 1.2) (K232102) | ClearPoint Neuro, Inc. | 2023-09-15 |
| Elecsys Anti-Tg (K222610) | Roche Diagnostics | 2023-09-15 |
| Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) (K232198) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| Sensis Vibe (VD15) (K223812) | Siemens Medical Solutions USA, Inc. | 2023-09-15 |
| Catalyst Bone Void Filler (K232315) | Ossdsign AB | 2023-09-15 |
| PENTO Nd:YAG and Alexandrite laser system (K231791) | Ilooda Co,., Ltd. | 2023-09-15 |
| NIDO™ Pedicle Screw System (K230974) | Kalitec Medical | 2023-09-15 |
| Barrier EasyWarm Active Self-Warming Blanket (K232508) | Molnlycke Health Care Us, LLC | 2023-09-15 |
| Perifix FX Catheter; Contiplex FX Catheter (K231242) | B.Braun Medical, Inc. | 2023-09-15 |
| Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (K230752) | FUJIFILM Healthcare Americas Corporation | 2023-09-15 |
| Avologi Gel Primer (Model: Av25) (K220735) | Premier North America, Inc. | 2023-09-15 |
| BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (K231827) | B.T.I. Biotechnology Institute, Sl. | 2023-09-15 |
| 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 (K230946) | Trax Surgical | 2023-09-15 |
| T2 Biothreat Panel (K231336) | T2biosystems, Inc. | 2023-09-15 |
| LW UCLA Abutment (K231235) | Ossvis Co., Ltd. | 2023-09-15 |
| Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) (K232199) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| Power wheelchair (Model:BC-EA8000) (K232121) | Ningbo Baichen Medical Devices Co., Ltd. | 2023-09-15 |
| Carnation series Diagnostic Ultrasound System (K230066) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2023-09-15 |
| Access Thyroglobulin (K220972) | Beckman Coulter, Inc. | 2023-09-15 |
| i-STAT G3+ cartridge with the i-STAT 1 System (K223857) | Abbott Point of Care, Inc. | 2023-09-15 |
| PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860) | Poonglim Pharmatech, Inc. | 2023-09-15 |
| Ambu® aScope™ Colon; Ambu® aBox™ 2 (K230332) | Ambu A/S | 2023-09-15 |
| 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) (K230237) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | 2023-09-14 |
| ThermPix Thermovisual Camera (K232462) | Usa Therm, Inc. | 2023-09-14 |
| Straumann® BLC and TLC Implants (K230108) | Institut Straumann AG | 2023-09-14 |
| cNeuro cPET (K231576) | Combinostics OY | 2023-09-14 |
| Non absorbable Surgical Polypropylene Suture (K230746) | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| VitreJect® Needle; OcuSafe® Needle (K230959) | Ocuject, LLC | 2023-09-14 |
| TEA Device (K230526) | Transtimulation Research, Inc. | 2023-09-14 |
| PureWay 1.4 Quart Sharps Collector (K231484) | Pureway Compliance, Inc. | 2023-09-14 |
| LightForce Orthodontic System (K232827) | Lightforce Orthodontics | 2023-09-14 |
| LW Retraction Cap (K231079) | Ossvis Co., Ltd. | 2023-09-14 |
| Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833) | Exactech, Inc. | 2023-09-14 |
| HOPKINS Telescopes (K223885) | Karl Storz Endoscopy America, Inc. | 2023-09-14 |
| CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (K232467) | Baxter Healthcare Corporation | 2023-09-14 |
| NEUROShield (K220034) | In-Med Prognostics L3c | 2023-09-14 |
| ChoiceSpine Blackhawk Ti Cervical Spacer System (K223869) | Choice Spine, LLC | 2023-09-14 |
| SOFIA EX Intracranial Support Catheter (K230775) | MicroVention, Inc. | 2023-09-14 |
| Anovo Pedestal (K232146) | Momentis Surgical , Ltd. | 2023-09-14 |
| Cove Putty, OsteoCove Putty (K231030) | SeaSpine Orthopedics Corporation | 2023-09-14 |
| Hammerdesis™ Interphalangeal Fusion System (K231147) | Intelivation | 2023-09-14 |
| Provecta 3D Prime and Provecta 3D Prime Ceph (K232487) | Durr Dental SE | 2023-09-14 |
| BACK 4 (K230167) | Swims America Corp | 2023-09-14 |
| AccuCTP Pro (K231353) | ArteryFlow Technology Co., Ltd. | 2023-09-14 |
| OrionXR (K232189) | Hoth Intelligence, Inc. | 2023-09-14 |
| FlowStar Analog Mixer Flowmeter (K230987) | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| IPL Hair Removal, Model: W-1095, W-1098 (K232124) | Shenzhen Wochuan Electronic Co., Ltd. | 2023-09-14 |
| Ultimate rTMS; Yingchi rTMS (K230735) | Brain Ultimate, Inc. | 2023-09-13 |
| GenX-CR (K232158) | Genoray Co., Ltd. | 2023-09-13 |
| AlloMap Heart Molecular Expression Testing (K221640) | Caredx, Inc. | 2023-09-13 |
| CRYOcheck Factor VIII Deficient Plasma with VWF (K222831) | Precision Biologic, Inc. | 2023-09-13 |
| AMSCO 600 Steam Sterilizer (K232485) | Steris | 2023-09-13 |
| Lung-CAD (K223811) | Imagen Technologies, Inc. | 2023-09-13 |
| ensoETM (DEN230021) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2023-09-13 |
| OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750) | OSSIO , Ltd. | 2023-09-13 |
| NG Delivery Catheter (K230609) | Balt USA, LLC | 2023-09-13 |
| Skyway Anterior Cervical Plate System (K231766) | Kyocera Medical Technologies Inc. (KMTI) | 2023-09-12 |
| Definium Pace Select (K231892) | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K231317) | Varian Medical Systems, Inc. | 2023-09-12 |
| Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) | Meridian AG | 2023-09-12 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) | Canon Medical Systems Corporation | 2023-09-12 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K231112) | Materialise NV | 2023-09-12 |
| Endure ETCO2/02 Nasal Cannula (K213767) | Endure Industries, Inc. | 2023-09-12 |
| Velacur (K232459) | Sonic Incytes | 2023-09-12 |
| Stone Extraction Baskets (K230598) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-09-12 |
| Cartesion Prime (PCD-1000A/3) V10.15 (K231748) | Canon Medical Systems Corporation | 2023-09-12 |
| Ablation-fit (K222938) | R.A.W. S.R.L | 2023-09-12 |