| Genomadix Cube CYP2C19 System (K220026) | Genomadix, Inc. | 2023-03-21 |
| FlightPlan for Embolization (K223490) | GE Medical Systems SCS | 2023-03-21 |
| Retraction, CWM-910T, APOLEX Tite (K222709) | Chungwoo Co., Ltd. | 2023-03-21 |
| LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (K230471) | Waldemar Link GmbH & Co. KG | 2023-03-21 |
| Entasis 3D Dual-Lead Sacroiliac Implant System (K223708) | Corelink, LLC | 2023-03-21 |
| TENS and EMS Stimulation (OTC) (K230163) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-03-20 |
| Colibrí (K223245) | Copan Wasp Srl | 2023-03-20 |
| Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A (K222828) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2023-03-20 |
| Shina Safety Needle (K222417) | Shina Corporation | 2023-03-20 |
| TENS and EMS Stimulation (OTC) (K230174) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-03-20 |
| MOBINEURO Alita Intraoperative MRI System (K223875) | Sino Canada Health Engineering Research Institute (Hefei) | 2023-03-20 |
| P-Cure Proton Beam Therapy System (K221996) | P-Cure, Ltd. | 2023-03-20 |
| HPR45i (K220725) | F Care Systems USA, LLC | 2023-03-20 |
| The Integrity Spine Core System (K223043) | Integrity Spine | 2023-03-20 |
| Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 |
| InterOss Collagen (K221808) | Sigmagraft, Inc. | 2023-03-18 |
| EOlife® (K221841) | Archeon | 2023-03-18 |
| LOQTEQ® VA Elbow Plates 2.7/3.5 System (K230141) | Aap Implantate AG | 2023-03-17 |
| Denture Base Resin (K230115) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-03-17 |
| Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (K221782) | Merit Medical Pte. , Ltd. | 2023-03-17 |
| Prism (K222101) | Graymatters Health , Ltd. | 2023-03-17 |
| Aevumed RAPID Suture Anchors (K223878) | Aevumed, Inc. | 2023-03-17 |
| FemDx FalloView (K221965) | Femdx Medsystems, Inc. | 2023-03-17 |
| Arthrex 3.9 mm SwiveLock Anchor (K230435) | Arthrex, Inc. | 2023-03-17 |
| EMPOWR Stem Extender, 50mm (K230441) | Encore Medical, L.P Dba Enovis | 2023-03-17 |
| NeuroRPM (K221772) | New Touch Digital, Inc. | 2023-03-17 |
| MagVenture TMS Atlas Neuro Navigation System (K221544) | Tonica Elektronik A/S | 2023-03-17 |
| DeGen Impulse AM™ System (K223418) | Degen Medical | 2023-03-17 |
| Ablacath™ Mapping Catheter (K223666) | Ablacon, Inc. | 2023-03-17 |
| Simplexa COVID-19 & Flu A/B Direct (K220963) | Diasorin Molecular, LLC | 2023-03-17 |
| Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162) | Healgen Scientific,, LLC | 2023-03-17 |
| SMR Stemless Anatomic (K221758) | Lima Corporate S.P.A. | 2023-03-17 |
| RCRP Flex reagent cartridge (K221119) | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 |
| Alio (K223073) | Alio, Inc. | 2023-03-17 |
| KARL STORZ Bipolar Resectoscopes with HF Cable (K221893) | Karl Storz Endoscopy America, Inc. | 2023-03-17 |
| Viz AAA (K223443) | Viz. Ai, Inc. | 2023-03-17 |
| InThrill Thrombectomy System (K223613) | Inari Medical, Inc. | 2023-03-17 |
| Senhance Surgical System (K223095) | Asensus Surgical, Inc. | 2023-03-16 |
| MilkMate Breast Pump (K223084) | Milkmate Products, Inc. | 2023-03-16 |
| Electric Wheelchair (K223393) | Shanghai Bangbang Robotics Co., Ltd. | 2023-03-16 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K223154) | Magstim Company, Ltd. | 2023-03-16 |
| Sterile Silver Alginate Wound Dressing (K220673) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2023-03-16 |
| BENCOX Delta Option Heads (K223828) | Corentec Co., Ltd. | 2023-03-16 |
| Ensmile (K222619) | Ensmile Pvt, Ltd. | 2023-03-16 |
| iSyncBrain©-C (K222838) | iMediSync, Inc. | 2023-03-16 |
| Nitrile Examination Gloves (K222813) | Ecoglove Medical Manufacturing Company Limited | 2023-03-16 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) | Biofire Diagnostics, LLC | 2023-03-16 |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (K222839) | Intuitive Surgical, Inc. | 2023-03-16 |
| Air Compression Leg Massager (model: EMK-701) (K222991) | Xiamen Emoka Health Science & Technology Co., Ltd. | 2023-03-15 |
| Digital Routines (K221924) | Gnc Holdings, LLC | 2023-03-15 |
| Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001) | Biomet Manufacturing Corp | 2023-03-15 |
| APEX 6 (K220122) | Rf Innovations, Inc. | 2023-03-15 |
| Precice Intramedullary Limb Lengthening System (K220234) | Nuvasive Specialized Orthopedics, Inc. | 2023-03-15 |
| ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) (K223760) | Ethicon Endo-Surgery | 2023-03-15 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. (K223375) | Kossan International Sdn Bhd3 | 2023-03-15 |
| LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (K230124) | Light Tree Ventures Europe B.V. | 2023-03-15 |
| iExaminer System with Panoptic Plus (K223381) | Welch Allyn, Inc. | 2023-03-15 |
| NeuroBlate Fusion-S Software V3.17 (K222983) | Monteris Medical, | 2023-03-15 |
| Tegamen Nitrile Examination Gloves (K223102) | M/S Tegamen Safety Products Private Limited | 2023-03-15 |
| Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137) | Hearx SA (Pty) , Ltd. | 2023-03-14 |
| RT Elements (4.0) (K223279) | Brainlab AG | 2023-03-14 |
| Leg and Foot Air Wave Pressure Therapy Device (K223464) | Zhangzhou Easepal Innovation CO , Ltd. | 2023-03-14 |
| ONE-CUF (K230145) | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 |
| HeartBuds Electronic Stethoscope (K212906) | Heartbuds, LLC | 2023-03-14 |
| SofWave System (K230019) | Sofwave Medical, Ltd. | 2023-03-14 |
| RevCore™ Thrombectomy Catheter. (K223609) | Inari Medical, Inc. | 2023-03-14 |
| JETT PLASMA Medical II (K213247) | Compex, Spol, S.R.O. | 2023-03-14 |
| Cervical Plate System (K223753) | Double Medical Technology, Inc. | 2023-03-14 |
| Surgical Face Mask (K221352) | Wuhan Huashida Protective Products Co., Ltd. | 2023-03-13 |
| Remi Robotic Navigation System (K223350) | Fusion Robotics, LLC | 2023-03-13 |
| Omnia Medical Coupler-C Anterior Cervical Plate (K223321) | Omnia Medical, LLC | 2023-03-13 |
| Aarhus Applicator Set (K222775) | Varian Medical Systems, Inc. | 2023-03-13 |
| Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954) | Innova Vision, Inc. | 2023-03-13 |
| High Protection Surgical Gown (K222456) | 3A Medical Products Co., Ltd. | 2023-03-12 |
| Arthrex Knotless FiberTak Suture Anchor (K230433) | Arthrex, Inc. | 2023-03-10 |
| CloudTMS for OCD (K221129) | Teleemg, LLC | 2023-03-10 |
| ATTUNE® Revision Cones (K230295) | Depuy Ireland UC | 2023-03-10 |
| FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (K221623) | Gme German Medical Engineering GmbH | 2023-03-10 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398) | Scientia Vascular, LLC | 2023-03-10 |
| uMI Panorama (K223325) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 |
| BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (K222478) | Becton, Dickinson and Company | 2023-03-10 |
| Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198) | Thermo Fisher Scientific | 2023-03-10 |
| Lyra RSV+hMPV Assay (K230349) | Quidel Corporation | 2023-03-10 |
| Avoset Infusion Pump System (K213744) | Eitan Medical , Ltd. | 2023-03-10 |
| Uni Knee Resurfacing System (K221292) | Overture Resurfacing, Inc. | 2023-03-10 |
| Vial Adapter (K222718) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023-03-10 |
| lntravascular Administration Sets with Stopcock and Manifold (K223175) | Baxter Healthcare Corporation | 2023-03-10 |
| Powered Muscle Stimulator (Model name:MagGraver F200) (K222875) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-03-09 |
| VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430) | Biomerieux Sa, Inc. | 2023-03-09 |
| Wesper Lab (K221816) | Wesper, Inc. | 2023-03-09 |
| CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) | Cerenovus, Inc. | 2023-03-09 |
| Spectral Bone Marrow (K223514) | Ge Medical Systems, LLC | 2023-03-09 |
| AccuContour (K221706) | Manteia Technologies Co., Ltd. | 2023-03-09 |
| CPS Locator 3D Delivery Catheter (K230363) | CenterPoint Systems, LLC | 2023-03-09 |
| MultiStage Balloon Dilatation Catheter (K222663) | Dongguan TT Medical, Inc. | 2023-03-09 |
| Vassallo GT 018 Hybrid (K223432) | Filmecc Co., Ltd. | 2023-03-09 |
| Electric breast pump (model: M5) (K223693) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-03-09 |
| Huvex Interspinous Fusion System (K223790) | Dio Medical Corp. | 2023-03-09 |
| DESS Dental Smart Solutions (K221301) | Terrats Medical SL | 2023-03-09 |
| CEREGLIDE 71 Intermediate Catheter (K221930) | Cerenovus, Inc. | 2023-03-09 |