| QStat Cartridge (K213917) | Hemosonics, LLC | 2022-11-29 |
| SmartSurgN Visualization System (K213943) | Smartsurgn Incorporated | 2022-11-29 |
| da Vinci E-200 Electrosurgical Generator (K223039) | Intuitive Surgical | 2022-11-28 |
| Aevumed PHANTOM™-LP Suture Anchors (K222363) | Aevumed, Inc. | 2022-11-28 |
| Male Latex Condoms (K222611) | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 |
| pNOVUS 21 Microcatheter (K221279) | Phenox, Ltd. | 2022-11-28 |
| TorchTM Software (K220630) | Voximetry, Incorporated | 2022-11-28 |
| Facet Manatee Reusable Lancing Base (K223099) | Facet Technologies, LLC | 2022-11-28 |
| Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (K211050) | Jkh Health Co., Ltd. | 2022-11-28 |
| Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer (K222652) | Cardicare Company, Ltd. | 2022-11-28 |
| T-Line Hernia Mesh (K221556) | Deep Blue Medical Advances, Inc. | 2022-11-28 |
| Momentum® MIS Posterior Spinal Fixation System (K223274) | Ulrich Medical USA | 2022-11-28 |
| Wireless/Wired X-Ray Flat Panel Detectors (K223009) | Allengers Medical Systems Limited | 2022-11-27 |
| VSI HoloMedicine (K213215) | Apoqlar GmbH | 2022-11-25 |
| DentCare Aligners (K222918) | Dentcare Dental Lab Pvt , Ltd. | 2022-11-25 |
| Powder-Free Latex examination gloves (K222612) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 |
| Ai Ray Dental X-Ray Device (K222569) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-23 |
| Nitrile Patient Examination Glove (K222534) | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 2022-11-23 |
| Closed System Transfer Device (K201460) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-11-23 |
| Disposable Automatically Retractable Safety Syringes (with detachable needle) (K222452) | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 |
| Glenoid Reconstruction System (K213459) | Medacta International S.A. | 2022-11-23 |
| Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (K222967) | Avanti Orthopaedics, Inc. | 2022-11-23 |
| CuringPen Dental Curing Light (K221152) | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 |
| EchoGo Heart Failure (K222463) | Ultromics Limited | 2022-11-23 |
| Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) (K221815) | Baisheng Medical Co., Ltd. | 2022-11-23 |
| PainShield MD PLUS (K221210) | Nanovibronix, Inc. | 2022-11-23 |
| LDE4 Lancing Device (K222656) | I-Sens, Inc. | 2022-11-23 |
| TempSure System (K223292) | Cynosure, LLC | 2022-11-23 |
| Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) (K223068) | Guangdong Golden Leaves Technology Development Co., Ltd. | 2022-11-23 |
| CINA (K221716) | Avicenna.Ai | 2022-11-22 |
| BioPoly Lesser Toe Hemiarthroplasty Implant (K222964) | BioPoly, LLC | 2022-11-22 |
| HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (K221704) | Edwards Lifesciences, LLC | 2022-11-22 |
| Denti.AI Auto-Chart (K222054) | Denti.Ai Technology, Inc. | 2022-11-22 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K222009) | Carlsmed, Inc. | 2022-11-22 |
| iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (K222992) | Innovative Bioceramix, Inc. | 2022-11-22 |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (K221608) | Anx Robotica Corp | 2022-11-22 |
| Canady Flex RoboWrist (K212736) | Us Medical Innovations, LLC | 2022-11-22 |
| Vision 2, EVARVision, TrackVision 2, HeartVision 2 (K223152) | GE Medical Systems SCS | 2022-11-22 |
| AccuCTP (K220663) | ArteryFlow Technology Co., Ltd. | 2022-11-22 |
| PRIMED Pediatric Facemask (K213427) | Primed Medical Products, Inc. | 2022-11-22 |
| ANNE Pediatric (K221530) | Sibel, Inc. | 2022-11-22 |
| VitroPRO (K222052) | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| LED Light Therapy Mask (model: MK66R-B) (K221946) | Light Tree Ventures Europe B.V. | 2022-11-22 |
| Renasys Edge (66803126) (K223041) | Smith & Nephew Medical Limited | 2022-11-22 |
| DynamicIQ (K222895) | GE Medical Systems SCS | 2022-11-22 |
| Minimally Invasive Prostate Surgery Navigation System (K221499) | Augment Intelligent Medical System (China) Co., Ltd. | 2022-11-22 |
| Avenda Health AI Prostate Cancer Planning Software (K221624) | Avenda Health, Inc. | 2022-11-22 |
| ARIX Rib System (K221412) | Jeil Medical Corporation | 2022-11-22 |
| E3 and Profile (K221471) | Diagnosys, LLC | 2022-11-22 |
| WISE Cortical Strip (WCS) (K221123) | Wise S.R.L. | 2022-11-22 |
| Cala kIQ (K222237) | Cala Health, Inc. | 2022-11-22 |
| da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) (K223080) | Intuitive Surgical, Inc. | 2022-11-22 |
| EasyOne Filter (K221250) | Ndd Medizintechnik AG | 2022-11-22 |
| GUS610 Blood pressure monitor (K222160) | Globalcare Medical Technology Co., Ltd. | 2022-11-22 |
| Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (K211507) | Beiang Air Tech , Ltd. | 2022-11-22 |
| CORE-SNARE (K220846) | Incore Co., Ltd. | 2022-11-21 |
| Pentax Medical Valve Set (K222980) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-11-21 |
| SR-1 Skin Treatment System (K221268) | AVAVA, Inc. | 2022-11-21 |
| Disposable Sterile Lancet (K222246) | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-21 |
| Vision Monitor- MonCvONE (K212936) | Metrovision | 2022-11-21 |
| Infusion Sets for Single Use with Needles (K221069) | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| Kowa SL-19 (K222372) | Kowa Company , Ltd. | 2022-11-21 |
| SIS System (Version 5.6.0) (K223032) | Surgical Information Sciences, Inc. | 2022-11-21 |
| Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (K221078) | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| Infusion Sets for Single Use (K221075) | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| Implanter incl. Accessories (K211358) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 |
| Flex-Thread™ Ulna Intramedullary Nail System (K222390) | Flower Orthopedics Corporation Dba Conventus Flower | 2022-11-21 |
| Disposable Blood Pressure Cuff (K222420) | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-11-21 |
| Vista BC Sealer (K221811) | Inter-Med, Inc. | 2022-11-21 |
| Miro3D Wound Matrix (K223257) | Reprise Biomedical | 2022-11-21 |
| SM-V (K222951) | Sedecal., Sa. | 2022-11-21 |
| Treace Medical Concepts (TMC) Implant Fixation System (K222645) | Treace Medical Concepts | 2022-11-21 |
| Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl (K221165) | Sri Trang Gloves (Thailand) Public Company Limited | 2022-11-20 |
| Empatica Health Monitoring Platform (K221282) | Empatica S.r.l. | 2022-11-20 |
| Single-Use Flexible Rhinolaryngoscope (K221581) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (K210623) | Sebia | 2022-11-18 |
| OCS Lung Donor Flush Set (K222535) | TransMedics, Inc. | 2022-11-18 |
| Tailored-H Cervical Stand Alone System (K222903) | Bespoke Technologies, LLC | 2022-11-18 |
| Konig Mogen Clamp (K212911) | Medline Industries, Inc. | 2022-11-18 |
| Single-Use Flexible Cystoscope (K221580) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| Opulent TiNbN Coated Knee (K222816) | Meril Healthcare Pvt. , Ltd. | 2022-11-18 |
| BriefCase (K221330) | Aidoc Medical , Ltd. | 2022-11-18 |
| Banded Face Mask (K223003) | Hubei Medlink Healthcare Co., Ltd. | 2022-11-18 |
| Auxilock GFS Mini, GFS II Large, and GFS Ultimate (K213018) | Auxein Medical Private Limited | 2022-11-18 |
| CONTOUR® NEXT GEN Blood Glucose Monitoring System (K223293) | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 |
| CODA™ Anterior Cervical Plate System (K222493) | Pioneer Surgical Technology, Inc. | 2022-11-18 |
| MANTA Laser (K222701) | Squalus Med , Ltd. | 2022-11-18 |
| SiOxD Wound Matrix (K222189) | Sioxmed, LLC | 2022-11-18 |
| Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (K223246) | Baxter Healthcare Corproration | 2022-11-18 |
| Polso Watch (K220351) | Chronisense Medical, Ltd. | 2022-11-18 |
| FBCC Night Guard (K221369) | Fbcc, Inc. | 2022-11-18 |
| Electromed SmartVest Airway Clearance System (K222496) | Electromed, Inc. | 2022-11-18 |
| Hair Growth Device (K222477) | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022-11-18 |
| COSY Cervicothoracic Occipital Rod-Screw System (K220658) | Signus Medizintechnik GmbH | 2022-11-18 |
| Facet Blood Lancets (K222539) | Facet Technologies, LLC | 2022-11-18 |
| Calibrate LTX Interbody System (K222455) | Alphatec Spine, Inc. | 2022-11-18 |
| EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG (K223124) | DRTECH Corporation | 2022-11-18 |
| Alexandrite and Nd:YAG Laser models CANLASE and TORLASE (K222673) | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-17 |
| MAVEN™ Patient-Specific Instrumentation (K223227) | Paragon 28, Inc. | 2022-11-17 |
| Disposable Urine Collection Tube (K220739) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022-11-17 |