| XPER Technology PREMIUM Pro Blood Glucose Monitoring System (K221349) | Taidoc Technology Corporation | 2024-11-19 |
| Medical Thulium Fiber Laser Systems (UroFiber 60Q) (K242293) | Rhein Laser Technologies Co., Ltd. | 2024-11-19 |
| EUROPA™ Posterior Cervical Fusion System (K242516) | MiRus, LLC | 2024-11-19 |
| XENOVIEW 3.0T Chest Coil (K243316) | Polarean, Inc. | 2024-11-19 |
| Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (K242496) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
| Natus BrainWatch System (K242930) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 |
| ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K242523) | Siemens Medical Solutions USA, Inc. | 2024-11-19 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813) | Nova Biomedical Corporation | 2024-11-19 |
| Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (K242028) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 |
| Tenex 2nd Generation System (K241700) | Trice Medical, Inc. | 2024-11-18 |
| Informed Vital Core Application (IVC App) (K241633) | Mindset Medical, Inc. | 2024-11-18 |
| MICRO Arterial Filters (K242092) | Sorin Group Italia S.R.L. | 2024-11-18 |
| Diode laser Treatment System (K18) (K241498) | Hebei Keylaser Sci-Tech Co.,Ltd | 2024-11-18 |
| Power wheelchair (K242402) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-11-18 |
| CT Collaboration Live (K242329) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-11-18 |
| da Vinci SP Instruments (SP1098) (K241814) | Intuitive Surgical, Inc. | 2024-11-18 |
| Montage-XT Settable Bone Putty (K243506) | Orthocon, Inc. | 2024-11-18 |
| Power Wheelchair (W5538) (K242471) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-11-18 |
| Saige-Dx (K241747) | DeepHealth, Inc. | 2024-11-18 |
| Synxess Neurovascular Guidewire (K240871) | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 |
| Air Pressure Therapy System (VU-IPC04B) (K243320) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-11-18 |
| Koios DS (K242130) | Koios Medical, Inc. | 2024-11-15 |
| ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (K241138) | Livsmed, Inc. | 2024-11-15 |
| ACUSON Redwood Diagnostic Ultrasound System (K243299) | Siemens Medical Solutions USA, Inc. | 2024-11-15 |
| 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K242419) | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024-11-15 |
| aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (K242260) | Carlsmed, Inc. | 2024-11-15 |
| b-ONE® Total Hip System (K240528) | B-One Ortho, Corp. | 2024-11-15 |
| 1CMR Pro (K242062) | Mycardium AI Limited | 2024-11-15 |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (K241439) | Vuno, Inc. | 2024-11-15 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| NUVENTUS NV.C™ Dental Implant System (K233081) | Infinitum Eta, Ltd. | 2024-11-15 |
| CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) | Blue Belt Technologies, Inc. | 2024-11-15 |
| TMINI Miniature Robotic System (K243285) | THINK Surgical, Inc. | 2024-11-15 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (K240523) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 |
| Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (K243306) | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 |
| EchoGo Amyloidosis (1.0) (K240860) | Ultromics Limited | 2024-11-15 |
| The 5000 Compact Series Ultrasound Systems (K242800) | Philips Ultrasound, LLC | 2024-11-15 |
| AdVance™ XP Male Sling System (720163-03) (K242960) | Boston Scientific Corporation | 2024-11-15 |
| VIVIX-S 1751S (K241125) | Vieworks Co., Ltd. | 2024-11-15 |
| Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360) | Dent4you AG | 2024-11-15 |
| Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (K241224) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024-11-15 |
| Fetal EchoScan (K242342) | Brightheart | 2024-11-14 |
| Xrecovery (XR-001) (K242940) | Shenzhen Xinrun Electric Appliances Co, Ltd. | 2024-11-14 |
| Proximal Humerus Fixation System (K242436) | Skeletal Dynamics, Inc. | 2024-11-14 |
| DEFINE System (AG612444A) (K242598) | InMode , Ltd. | 2024-11-14 |
| Veincare (K241930) | Wontech Co., Ltd. | 2024-11-14 |
| Tandry Q-Locking Plate System (K242814) | Microware Precision Co., Ltd. | 2024-11-14 |
| Hinscope (K241397) | Hinlab Sas | 2024-11-14 |
| Arthrex Elbow Fracture Plating System (K242079) | Arthrex, Inc. | 2024-11-14 |
| Intense Pulsed Light Treatment System (LK-PT) (K242440) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| Besmed Bacterial Filter and HMEF (K241339) | Besmed Health Business Corp | 2024-11-14 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K243273) | Cequr SA | 2024-11-13 |
| Nonin OTC Pulse Oximeter Model 3250 (K211498) | Nonin Medical, Inc. | 2024-11-13 |
| MediRod Pedicle Screw System (K242764) | Cmf Medicon Surgical, Inc. | 2024-11-13 |
| Dental Glass Ceramics Blocks (HT, LT, MT) (K242407) | Hunan Vsmile Biotechnology Co., Ltd. | 2024-11-13 |
| Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (K240337) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-11-13 |
| RESPOND(R) Ventilator (K241135) | Corvent Medical, Inc. | 2024-11-13 |
| LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (K242856) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 |
| SmartFlow Neuro Cannula (DEN240023) | ClearPoint Neuro, Inc. | 2024-11-13 |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173) | Coloplast Corp. | 2024-11-12 |
| Electric wheelchair (KR-8807) (K242791) | Zhejiang Kairui Medical Device Co., Ltd. | 2024-11-12 |
| pNOVUS 21 Microcatheter (K242420) | Phenox, Ltd. | 2024-11-12 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| Aurelia Surgical Mask ASTM Level-3 (2130) (K242502) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 |
| PRORAD X-Ray Flat Panel Detector with DROC (K240771) | Prognosys Medical Systems Private Limited | 2024-11-12 |
| VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (DEN230085) | Steris | 2024-11-12 |
| AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (K230915) | Vyaire Medical, Inc. | 2024-11-12 |
| Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) (K242430) | Soul Mobility | 2024-11-12 |
| High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (K241074) | Foshan Soco Precision Instrument Co., Ltd. | 2024-11-12 |
| UbiqVue™ 2A Multi-parameter System (UX2550) (K242018) | Lifesignals, Inc. | 2024-11-12 |
| Change Healthcare Stratus Imaging PACS (K241981) | Change Healthcare Canada Company | 2024-11-12 |
| Straumann® Anatomic Healing Abutments XC (AHA) (K241575) | Straumann USA, LLC | 2024-11-11 |
| esolution® Esophageal Retractor (K243233) | S4 Medical Corp. | 2024-11-09 |
| Hybrid Viewer (00859873006189) (K241364) | Hermes Medical Solutions AB | 2024-11-08 |
| Superflow Prime Treatment System (ASP-1M) (K242286) | Guangzhou Aimira Innovation Technology Co, Ltd. | 2024-11-08 |
| Microdacyn Hydrogel (K240510) | Sonoma Pharmaceuticals, Inc. | 2024-11-08 |
| CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (K242802) | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 |
| MobileLink Acetabular Cup System - Line Extension (Multiple) (K241636) | Waldemar Link GmbH & Co. KG | 2024-11-08 |
| décoLITE LED Device (K242382) | iSMART Developments, Ltd. | 2024-11-08 |
| ProFound Detection (V4.0) (K240417) | Icad, Inc. | 2024-11-08 |
| TopCEM Ceramic Primer Ceramic Coupling Agent (K242749) | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| Xpine Spinal Fixation System (K243004) | Jeil Medical Corporation | 2024-11-08 |
| Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (K242231) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-11-08 |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075) | STERIS Corporation | 2024-11-08 |
| Hair Growth Comb (SZ-23,SZ-23A) (K241342) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-11-08 |
| Trigon PEEK HA Wedges (K243231) | Nvision Biomedical Technologies | 2024-11-08 |
| Plasonic (Plasonic) (K241099) | Hironic Co., Ltd. | 2024-11-08 |
| Device 300397 Putty (K241802) | Geistlich Pharma AG | 2024-11-08 |
| Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (K242756) | Pulnovo Medical (Wuxi) Co., Ltd. | 2024-11-08 |
| Frontier X Plus (K240794) | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 |
| Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (K242595) | Shenzhen Greatro Electronic Technology Co., Ltd. | 2024-11-07 |
| Mako Shoulder Application (1.0) (K242373) | Mako Surgical Corp. | 2024-11-07 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) | Biofire Diagnostics, LLC | 2024-11-07 |
| ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (K242734) | Zsfab | 2024-11-07 |
| Remanufactured EndoWrist ProGrasp Forceps (420093) (K241872) | Rebotix | 2024-11-07 |
| MicroTrend System (K212425) | Exostat Medical, Inc. | 2024-11-07 |
| OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (K242361) | Stryker Spine | 2024-11-07 |
| IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (K241346) | Aspen Imaging Healthcare, Inc. | 2024-11-07 |
| NeuroICH (K241719) | Neurocareai, Inc. | 2024-11-07 |