| Accure Laser (K222109) | Accure Acne, Inc. | 2022-11-17 |
| FX Contra (K222518) | Nakanishi, Inc. | 2022-11-17 |
| Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (K221593) | Convatec, Inc. | 2022-11-17 |
| IPL Hair Removal Device (K222598) | Shenzhen Noble Smart Manufacturing Tech Co., Ltd. | 2022-11-17 |
| SKR 3000 (K223267) | Konica Minolta, Inc. | 2022-11-17 |
| C.C. LIFE 21 (K213295) | 21 Equipment S.R.L. | 2022-11-17 |
| Disposable Insulin Pen Needle (K221178) | Ningbo Medsun Medical Co., Ltd. | 2022-11-17 |
| Parky App (K220820) | H2o Bilisim Yazilim | 2022-11-17 |
| Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (K222208) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-11-17 |
| Blood Administration Sets (K220558) | Baxter Healthcare Corporation | 2022-11-17 |
| Multitom Rax (K221281) | Siemens Medical Solutions | 2022-11-17 |
| Persona Personalized Knee System (K221479) | Zimmer, Inc. | 2022-11-17 |
| OmegaAI Image Viewer (K222476) | Ramsoft, Inc. | 2022-11-17 |
| IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (K222973) | Alphatec Spine, Inc. | 2022-11-17 |
| Dentca Base Premium, Dentca Base Hi-Impact (K220042) | Dentca, Inc. | 2022-11-17 |
| Supra Non-Stick Bipolar Forceps (K213042) | Guenter Bissinger Medizintechnik GmbH | 2022-11-17 |
| Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece (K212910) | Shenzhen Carejoy Technology Co., Ltd. | 2022-11-17 |
| easy Claire (K223278) | Y & J Bio Co., Ltd. | 2022-11-17 |
| TFX-LT2000 Therapy Light (K211265) | Toefx, Inc. | 2022-11-17 |
| xvision Spine System (K220905) | Augmedics, Ltd. | 2022-11-17 |
| KNH Surgical Face Mask (K203528) | Knh Surgical Face Mask | 2022-11-16 |
| PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 (K220465) | Pentax of America, Inc. | 2022-11-16 |
| Life Spine ALIF Buttress Plate System (K222628) | Life Spine, Inc. | 2022-11-16 |
| Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) (K222364) | Xtrallux, LLC | 2022-11-16 |
| Disposable surgical face mask (K220302) | Shandong Aida Medical Products Co., Ltd. | 2022-11-16 |
| PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (K220841) | Dentsply Sirona | 2022-11-16 |
| OmniTaper EV Dental Implants, DS Implants abutments with EV connection (K221094) | Dentsply Sirona | 2022-11-16 |
| Surgical Gown (K212812) | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 |
| Heater-Cooler System 3T (K220635) | Livanova Deutschland, GmbH | 2022-11-16 |
| Endoscopy Oxygen Mask (K220533) | Engineered Medical Systems, Inc. | 2022-11-16 |
| BoneMRI v1.4 (K221762) | Mrlguidance B.V. | 2022-11-16 |
| Bloomi Delight Oil-Based Personal Lubricant (K222175) | The Bloomi Inc.. | 2022-11-15 |
| Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS (K222915) | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-15 |
| STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K221744) | ETHICON, Inc. | 2022-11-15 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (K221722) | Haemonetics Corporation | 2022-11-15 |
| Everyway Analog OTC TENS (K222488) | Everyway Medical Instruments Co.,Ltd | 2022-11-15 |
| Dyflex-II (K212700) | Taeyeon Medical Co., Ltd. | 2022-11-15 |
| Disposable Sterile Lancet (K222055) | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-15 |
| Omnia Medical TiBrid-SC (K212612) | Omnia Medical, LLC | 2022-11-15 |
| Cardio10 (K220535) | Bionet Co., Ltd. | 2022-11-15 |
| Treace Medical Concepts (TMC) Hammertoe Fixation System (K222564) | Treace Medical Concepts, Inc. | 2022-11-15 |
| ALPHALOK Plating System (K221558) | Vilex, LLC | 2022-11-15 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
| 2.1 x 255mm Drill, 22mm Stop (K223199) | Biomet Microfixation | 2022-11-15 |
| Gamma4 System (K222309) | Stryker GmbH | 2022-11-15 |
| Multiflex Steerable Sheath (K221655) | Vizaramed, Inc. | 2022-11-14 |
| High Fluid-Resistant Surgical and Procedure Mask (K222749) | America’S Supply Chains | 2022-11-14 |
| HBL Blade Assembly (K222490) | Hand Biomechanics Lab, Inc. | 2022-11-14 |
| Smith & Nephew Intramedullary Nail Systems (K210980) | Smith & Nephew, Inc. | 2022-11-14 |
| Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (K222480) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 |
| Disposable hemoclip (K213217) | Beijing Zksk Technology Co., Ltd. | 2022-11-14 |
| Zirconia Block (K222520) | Yilink (Tianjin) Biotechnology Co., Ltd. | 2022-11-14 |
| PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326) | Hemostasis, LLC | 2022-11-14 |
| Hexanium ACIF (K221578) | Spinevision, S.A.S. | 2022-11-14 |
| uPMR 790 (K222540) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| Surgical Face Mask (K222529) | Xiantao Rayxin Medical Products Co., Ltd. | 2022-11-14 |
| Syngo Dynamics (Version VA40F) (K222428) | Siemens Medical Solutions USA, Inc. | 2022-11-14 |
| Nitrile Examination Gloves (K213981) | Emerald Glove Manufacturing Sdn Bhd | 2022-11-12 |
| Mapping Suction Probe (K212164) | Inomed Medizintechnik GmbH | 2022-11-11 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) (K222225) | Hartalega NGC Sdn. Bhd. | 2022-11-11 |
| ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System (K220983) | Imsonic Medical China, Inc. | 2022-11-11 |
| H1 (K222504) | Karl Storz Endoscopy America, Inc. | 2022-11-10 |
| WOLF Thrombectomy™ SmartClaw Catheter (K221391) | Devoro Medical, Inc. | 2022-11-10 |
| BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (K223198) | Bard Access Systems | 2022-11-10 |
| TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (K220562) | Megagen Implant Co., Ltd. | 2022-11-10 |
| AMSure Enteral Feeding Pump (K220230) | Amsino International, Inc. | 2022-11-10 |
| Dental LT Clear V2 Resin (K222061) | Formlabs Ohio, Inc. | 2022-11-10 |
| Catalyst EA Convertible Stemmed Shoulder (K222317) | Catalyst Orthoscience, Inc. | 2022-11-10 |
| SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K222067) | Quanta Dialysis Technologies, Ltd. | 2022-11-10 |
| AEYE-DS (K221183) | Aeye Health, Inc. | 2022-11-10 |
| FUJIFILM Endoscope Model EB-710P (K220957) | Fujifilm Corporaton | 2022-11-10 |
| SprintRay High Impact Denture Base (K221678) | Sprintray, Inc. | 2022-11-10 |
| APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg (K211934) | Boston Scientific Corporation | 2022-11-10 |
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |
| Dermal Cooling System (K213294) | R2 Technologies, Inc. | 2022-11-10 |
| SNOR LOCK (K222475) | Solbaro Co., Ltd. | 2022-11-10 |
| Humask Pro Vision, Humask Pro Vision 3000 (K222551) | Entreprise Premont, Inc. | 2022-11-10 |
| 10PL (K220794) | Tentech Co. , Ltd. | 2022-11-10 |
| Bodygard SFS Surgical Gown Level 4 (K221139) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 |
| Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (K222667) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 |
| BreathID® Smart System (K223185) | Meridian Bioscience Israel , Ltd. | 2022-11-10 |
| Tandry CMF Plate System (K220360) | Microware Precision Co., Ltd. | 2022-11-10 |
| Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (K211954) | Spes Medica Srl | 2022-11-10 |
| Synapse 3D Base Tools v6.6 (K221677) | Fujifilm Corporation | 2022-11-10 |
| AVIEW RT ACS (K220408) | Coreline Soft Co., Ltd. | 2022-11-10 |
| AquaPulse® Irrigation Tubing (K223171) | Ga Health Company Limited | 2022-11-10 |
| Eonis SCID-SMA kit (K203035) | Perkinelmer, Inc. | 2022-11-09 |
| Exo Iris (El2001) (K222198) | Exo Imaging, Inc. | 2022-11-09 |
| Eonis SCID-SMA Kit (DEN200044) | Perkinelmer, Inc. | 2022-11-09 |
| SOLIX (K222166) | Optovue, Inc. | 2022-11-09 |
| GammaTile (K221539) | Gt Medical Technologies | 2022-11-09 |
| ViewMate Multi Ultrasound System (K222754) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-11-09 |
| Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K222162) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 |
| Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (K223132) | Iridex Corporation | 2022-11-09 |
| Universal CMF System (K221855) | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
| Zaga Zygomatic System (K222497) | Southern Implants (Pty), Ltd. | 2022-11-09 |
| MONET Anterior Cervical Plate System (K220334) | Ctl Medical Corporation | 2022-11-09 |
| SelectSite C304 Deflectable Catheter System, C315 Delivery System (K223178) | Medtronic | 2022-11-08 |
| Sysmex XW-100 Automated Hematology Analyzer (K210346) | Sysmex America, Inc. | 2022-11-08 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K222304) | Gynesonics, Inc. | 2022-11-08 |