| Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (K241853) | Varian Medical Systems, Inc. | 2024-11-07 |
| VioSeal (K242702) | Spident Co., Ltd. | 2024-11-07 |
| LL Implant System (K242379) | Ossvis Co., Ltd. | 2024-11-07 |
| Vertiwedge® Intraosseous System (K241468) | Foundation Surgical Group, Inc. | 2024-11-07 |
| icobrain aria (K240712) | Icometrix NV | 2024-11-07 |
| Newclip Patient-matched instrumentation non sterile PSI (K240415) | Newclip Technics | 2024-11-07 |
| Trilogy Tissue Marker (K240429) | Inrad, Inc. | 2024-11-07 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) | ABBOTT MEDICAL | 2024-11-06 |
| Citrepore™ (K240450) | Acuitive Technologies, Inc. | 2024-11-06 |
| Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) (K242039) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-11-06 |
| BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (K243222) | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 |
| Compound W Skin Tag Remover (K242803) | Medtech Products, Inc. | 2024-11-06 |
| ELEXIR 2.0 (ALLIVE3) (K242719) | Nu Eyne Co., Ltd. | 2024-11-06 |
| Agility Symmetric™ Total Knee System (K242412) | Medisurge, LLC | 2024-11-06 |
| MultiCut Solo (K240831) | Asclepion Laser Technologies GmbH | 2024-11-06 |
| Accelx Implant System (K242261) | Biotech Dental, LLC | 2024-11-06 |
| CarboClear® Hybrid Pedicle Screw System (K243106) | CarboFix Orthopedics , Ltd. | 2024-11-05 |
| Delphi Stimulator (K242345) | Quantalx Neuroscience | 2024-11-05 |
| POTENZA (K231287) | Jeisys Medical, Inc. | 2024-11-05 |
| Atlas™ Humeral Nail System (K241484) | Orthopedic Designs North America, Inc. (Odi-Na) | 2024-11-05 |
| MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (K241849) | Imaxeon Pty, Ltd. | 2024-11-05 |
| Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) (K242332) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2024-11-05 |
| InfuLife (K240624) | First Medical Source, LLC | 2024-11-05 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (K242947) | Cardio Flow Inc., | 2024-11-05 |
| TeraRecon Cardiac.Chambers.MR (1.0.0) (K241312) | Terarecon,Inc. | 2024-11-05 |
| DESS Dental Smart Solutions (K242340) | Terrats Medical SL | 2024-11-05 |
| gentleheel® Adult Incision Device (K242664) | Gri-Alleset, Inc. | 2024-11-05 |
| Skyway Anterior Cervical Plate System (K243015) | Kyocera Medical Technologies, Inc. | 2024-11-05 |
| Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (K242567) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-11-04 |
| JLK-PWI (K242709) | JLK, Inc. | 2024-11-04 |
| SonoStik Guide Wire Introducer (K243061) | Sonostik, LLC | 2024-11-04 |
| Tixel i (TXLI0001) (K240512) | Novoxel , Ltd. | 2024-11-04 |
| Valeda Light Delivery System (DEN230083) | Lumithera, Inc. | 2024-11-04 |
| CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (K240438) | Comercializadora Brever | 2024-11-04 |
| RIGHTEST Blood Glucose Monitoring System Max Tel (K240637) | Bionime Corporation | 2024-11-04 |
| Gemini Cervical Fusion Cage System (K242195) | ZheJiang Decans Medical Devices Co., Ltd. | 2024-11-04 |
| SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (K242269) | Quanta Dialysis Technologies, Ltd. | 2024-11-01 |
| Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (K240881) | Covidien (Part of Medtronic) | 2024-11-01 |
| Osteotomy Truss System (OTS) (K240388) | 4Web Medical, Inc. | 2024-11-01 |
| Over-tube (TR-1108A) (K243091) | Fujifilm Corporation | 2024-11-01 |
| EXPERT - Flexible Joint Fixation System (K242311) | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (K240366) | Boston Scientific Corporation | 2024-11-01 |
| AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514) | Applied Medical Technology, Inc. | 2024-11-01 |
| VersaCross™ RF Wire (K242076) | Baylis Medical Company | 2024-11-01 |
| DePuy ATTUNE™ Total Knee System (K242665) | Depuy Orthopedics, Inc. | 2024-11-01 |
| uDR 780i (K241068) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| Breo Laser Hair Growth Comb (Scalp 3L) (K242620) | Shenzhen Breo Technology Co., Ltd. | 2024-11-01 |
| XERO-alpha (K242591) | DRTECH Corporation | 2024-11-01 |
| Prophecy Surgical Planning System (K241999) | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 |
| BD Vacutainer® One Use Holder (K242320) | Becton, Dickinson and Company | 2024-11-01 |
| Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393) | Acuity Polymers, Inc. | 2024-11-01 |
| Total Wrist Arthroplasty System (TWA) (K243381) | Skeletal Dynamics, Inc. | 2024-11-01 |
| ORTIV (ORTIV-BL, ORTIV-WH) (K241646) | Mvitro Co., Ltd. | 2024-11-01 |
| Monkey Bars Pin to Bar External Fixation System (K242452) | Paragon 28, Inc. | 2024-11-01 |
| Legend X Desktop System (K243217) | Pollogen, Ltd. | 2024-11-01 |
| Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828) | Medtronic, Inc. | 2024-11-01 |
| FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (K242675) | Spident Co., Ltd. | 2024-11-01 |
| PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (K242328) | Bard Access Systems, Inc. | 2024-10-31 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (K243181) | Bionova Medical, Inc. | 2024-10-31 |
| SmartCardia 7L Platform (MCT) (K240653) | Smartcardia SA | 2024-10-31 |
| Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (K242623) | Shenzhen Medke Technology Co., Ltd. | 2024-10-31 |
| BD Vacutainer® Citrate Blood Collection Tubes (K240455) | Becton, Dickinson and Company | 2024-10-31 |
| V80 Anesthetic Vaporizer (V80) (K240375) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-10-31 |
| Bonebridge Osteosynthesis Plating System (K242399) | Bonebridge AG | 2024-10-31 |
| Highness Implant System (K240383) | Highness Co., Ltd. | 2024-10-31 |
| eRAD PACS (K241223) | Erad, Inc. | 2024-10-31 |
| Stone Clear (SC-LP9-01) (DEN230082) | Sonomotion, Inc. | 2024-10-30 |
| Safety Lancet (K242627) | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (K243186) | Siemens Medical Solutions USA, Inc. | 2024-10-30 |
| Wearable Digital Thermometer (T31) (K240333) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| RemedyLogic AI MRI Lumbar Spine Reader (K241108) | Remedy Logic, Inc. | 2024-10-30 |
| Zio AT® device (A100A1001) (K240177) | iRhythm Technologies, Inc. | 2024-10-30 |
| MedicCO2LON (MedicCO2LON) (K240847) | Ide Vision, Ltd. | 2024-10-30 |
| DRI Ecstasy Plus Assay (K240670) | Microgenics Corporation | 2024-10-30 |
| JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (K242711) | Smith & Nephew, Inc. | 2024-10-30 |
| NeurAxis IB-Stim (01-1020) (K241533) | Neuraxis | 2024-10-30 |
| Caduceus S (K242271) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 |
| LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) (K240334) | Lagis Enterprise Co., Ltd. | 2024-10-30 |
| Edison System (K241902) | HistoSonics, Inc. | 2024-10-30 |
| ZENEX Implant System_Long (K240560) | Izenimplant Co., Ltd. | 2024-10-30 |
| Persona the Personalized Knee System (K243247) | Zimmer, Inc. | 2024-10-29 |
| Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175) | Tigon Medical | 2024-10-29 |
| Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (K241612) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-29 |
| DeGen Medical Patient Specific Implant (PSI) System (K241077) | Degen Medical | 2024-10-29 |
| Riptide Aspiration System (K243080) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-10-29 |
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| TRACHEOBRONXANE™ DUMON® (K243126) | Novatech SA | 2024-10-29 |
| QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) (K241366) | Dehas Medical Systems GmbH | 2024-10-29 |
| Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095) | Devicor Medical Products, Inc. | 2024-10-29 |
| Catheter Surface Flap Applicator Set (GM11011830) (K241965) | Varian Medical Systems | 2024-10-29 |
| Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) (K241189) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. | 2024-10-29 |
| OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (K243203) | Riverpoint Medical | 2024-10-29 |
| AtriCure cryoICE BOX (ACM) (K243157) | AtriCure, Inc. | 2024-10-29 |
| Sterile Lancets for Single Use (K242622) | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 |
| Curiteva Porous PEEK Laminoplasty System (K243137) | Curiteva, Inc. | 2024-10-28 |
| Catalyft™ LS Expandable Interbody System (K241992) | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 |
| Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (K242350) | Spinal Alignment Solutions, Inc. | 2024-10-28 |
| Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K241718) | Shenzhen Aozemei Technology Co., Ltd. | 2024-10-28 |
| MetaLite DX Digital Pathology Software (K240303) | Jellox Biotech, Inc. | 2024-10-28 |
| ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (K241630) | Ethicon Endo-Surgery, LLC | 2024-10-28 |