| Power Wheelchair, W5521 (K231508) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-11-09 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408) | Materialise NV | 2023-11-09 |
| LILY Extension Tube and Needleless Connector (K222780) | Lily Medical Corporation | 2023-11-09 |
| Longeviti ClearFit OTS Cranial Implant (K231920) | Longeviti Neuro Solutions, LLC | 2023-11-09 |
| VarseoSmile TriniQ (K233596) | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023-11-09 |
| NerivioInfinity (K232152) | Theranica Bioelectronics , Ltd. | 2023-11-08 |
| INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (K232886) | Healthium Medtech Limited | 2023-11-08 |
| Dream Sock (DEN220091) | Owlet Babycare, Inc. | 2023-11-08 |
| BriefCase-Quantification (K230534) | Aidoc Medical , Ltd. | 2023-11-08 |
| Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U (K231773) | Qura S.R.L | 2023-11-08 |
| VS Tabletop Tonometer (K223739) | Medimaging Integrated Solution, Inc. | 2023-11-08 |
| Cure Catheter Closed System; Cure Dextra Closed System (K230400) | Convatec, Inc. | 2023-11-08 |
| da Vinci SP Surgical System (K231798) | Intuitive Surgical, Inc. | 2023-11-08 |
| Contour ProtégéAI (K231765) | Mim Software, Inc. | 2023-11-08 |
| Peridot-EX Expandable Intervertebral Body Fusion System (K232292) | Gbs Commonwealth Co., Ltd. | 2023-11-07 |
| Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) (K232866) | Jiangsu Channel Medical Device Co., Ltd. | 2023-11-07 |
| Axium Detachable Coil; Axium Prime Detachable Coil (K233420) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 |
| Disposable Sphincterotome (K232476) | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 |
| Biodegradable Medical surgical mask (K231155) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-11-07 |
| LOGIQ E10s, LOGIQ Fortis (K231989) | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-07 |
| LOGIQ E10 (K231966) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-11-07 |
| Revital Cady (K231519) | Revital Healthcare (Epz) Limited | 2023-11-06 |
| Mouth Guard (ATG0603R) (K231865) | Reazeal Corp | 2023-11-06 |
| Lunit INSIGHT DBT (K231470) | Lunit, Inc. | 2023-11-06 |
| KARL STORZ ICG Imaging System (K232857) | Karl Storz SE & CO. KG | 2023-11-06 |
| EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) (DEN220090) | Stemcell Technologies Canada, Inc. | 2023-11-06 |
| Aptima Trichomonas vaginalis Assay (K231316) | Hologic, Inc. | 2023-11-06 |
| t:slim X2 Insulin Pump with Interoperable Technology (K232380) | Tandem Diabetes Care, Inc. | 2023-11-03 |
| SCIZER (SC1-M410) (K230100) | Classys, Inc. | 2023-11-03 |
| Evenflo Premium Double Electric Breast Pump (Model 4018) (K230481) | Evenflo Feeding, Inc. | 2023-11-03 |
| Control-IQ Technology (K232382) | Tandem Diabetes Care, Inc. | 2023-11-03 |
| aprevo® Digital Segmentation (K231955) | Carlsmed, Inc. | 2023-11-03 |
| Arthrex FiberTak Suture Anchor (K232742) | Arthrex, Inc. | 2023-11-03 |
| APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (K232251) | Medartis AG | 2023-11-03 |
| TRAX® CR Total Knee System (K230078) | Amplitude | 2023-11-03 |
| ProSeal™ Closed System Administration Set (K230343) | Epic Medical Pte. , Ltd. | 2023-11-03 |
| GripTract-GI Endoscopic Tissue Manipulator (K231254) | Actuated Medical, Inc. | 2023-11-03 |
| Halcyon, Ethos Radiotherapy System (K232113) | Varian Medical Systems, Inc. | 2023-11-03 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (K231182) | Zoll Circulation, Inc. | 2023-11-03 |
| Endophys Blood Pressure Monitor model BPM-30 (K231586) | Endophys Technologies, LLC | 2023-11-03 |
| Combo Electrotherapy Device (K231440) | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter (K231918) | Koru Medical Systems | 2023-11-03 |
| ManaFlexx 2 (model: MF002-RX, MF002-OTC) (K231569) | Manamed, Inc. | 2023-11-03 |
| Medical Video Endoscope System (K230475) | Huger Medical Instrument Co., Ltd. | 2023-11-03 |
| Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266) | Better Care Plastic Technology Co., Ltd. | 2023-11-03 |
| Easycess Aspiration Pump (K233428) | Guangzhou Easycess Medical Co.,Ltd | 2023-11-03 |
| LOGIQ e (K232186) | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-03 |
| EpiZact (K233056) | Guidestar Medical Devices | 2023-11-02 |
| Fibercure (K232076) | Lumendo AG | 2023-11-02 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (K233407) | AtriCure, Inc. | 2023-11-02 |
| STELLAR Knee (K232176) | Polarisar, Inc. | 2023-11-02 |
| ENFit to ENFit Extension Sets (K230326) | Vesco Medical | 2023-11-02 |
| VersaWrap Nerve Protector (K232029) | Alafair Biosciences, Inc. | 2023-11-02 |
| ATEC Posterior Navigated Disc Prep Instruments (K232345) | Alphatec Spine, Inc. | 2023-11-02 |
| XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 (K230800) | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 |
| Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725) | Suzhou Endophix Co., Ltd. | 2023-11-02 |
| BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (K233062) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 |
| BASE290 LED Curing Light (K233518) | Handpiece Headquarters | 2023-11-02 |
| Nd:Yag Laser Therapy Systems (K232532) | Beijing Unt Technology Co., Ltd. | 2023-11-02 |
| Bard 3DMax Mesh (K233402) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| Aventus Thrombectomy System (K232730) | Inquis Medical | 2023-11-01 |
| CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414) | Chalice Medical , Ltd. | 2023-11-01 |
| Inzii Ripstop Redeployable Retrieval System (K232880) | Applied Medical Resources Corporation | 2023-11-01 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K230927) | Spineology, Inc. | 2023-11-01 |
| TERA HARZ II (K233502) | Graphy, Inc. | 2023-11-01 |
| Neodent Implant System - GM Zygomatic Implant System (K232099) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-10-31 |
| SAFIRA (K230083) | Medovate Limited | 2023-10-31 |
| OCS Heart Leukocyte Depleting Filter (K231362) | TransMedics, Inc. | 2023-10-31 |
| LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320) | Medtronic, Inc. | 2023-10-31 |
| EVOLUTION® Cement Keel (K231947) | Microport Orthopedics, Inc. | 2023-10-31 |
| Tornier Humeral Nail and Tornier Long Humeral Nail (K230352) | Tornier, Inc. | 2023-10-31 |
| VRNT (K230814) | Cognifisense, Inc. | 2023-10-31 |
| VICTORY™ Lumbar Plate System (K232318) | Globus Medical, Inc. | 2023-10-31 |
| Finger Clip Pulse Oximeter (K231243) | Guangdong Genial Technology Co., Ltd. | 2023-10-31 |
| Hudson RCI® TurboMist™ Nebulizer System (K230602) | Medline Industries, LP | 2023-10-31 |
| Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (K231298) | Alesi Surgical, Ltd. | 2023-10-31 |
| HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) (K232294) | Edwards Lifesciences, LLC | 2023-10-31 |
| Ultravision2™ System (K231238) | Alesi Surgical, Ltd. | 2023-10-31 |
| Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 (K231868) | Shanghai Bangbang Robotics Co., Ltd. | 2023-10-31 |
| Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml (K232310) | Thermo Fisher Scientific | 2023-10-31 |
| 091 Balloon Guide Catheter (K231629) | Eosolutions, Corp. | 2023-10-31 |
| FlexCath Contour™ Steerable Sheath (K232321) | Medtronic, Inc. | 2023-10-31 |
| Speedboat Flush SB1 Instrument (K230328) | Creo Medical, Ltd. | 2023-10-31 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K230457) | Empatica S.r.l. | 2023-10-30 |
| BriefCase-Triage (K232751) | Aidoc Medical , Ltd. | 2023-10-30 |
| Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (K231965) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-10-30 |
| Renova Spine Balloon Catheter (K231340) | Biopsybell S.R.L. | 2023-10-30 |
| ClariVy™ Cervical IBF System (K231836) | Vy Spine, LLC | 2023-10-30 |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System (K232145) | Siemens Medical Solutions USA, Inc. | 2023-10-30 |
| Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl (K231029) | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-30 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222) | Topcon Corporation | 2023-10-30 |
| NuEra Tight RF Model OptiStream (K230755) | Bios S.R.L. | 2023-10-30 |
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |
| AOT & T-L Abutment (K231874) | Truabutment, Inc. | 2023-10-30 |
| NextAR™ TSA Platform (K232280) | Medacta International S.A. | 2023-10-29 |
| Mighty Wire Guide Wire (K230418) | Merit Medical Systems, Inc. | 2023-10-28 |
| AcuNav Crystal Ultrasound Catheter (K233270) | Siemens Medical Solutions USA, Inc. | 2023-10-28 |
| RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (K232348) | MiRus, LLC | 2023-10-27 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292) | Inomed Medizintechnik GmbH | 2023-10-27 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230285) | Abbott Point of Care, Inc. | 2023-10-27 |