| Emanate Tray (K251908) | Emanate Biomedical | 2026-07-29 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| SPINEART Navigation Instrument System (K261205) | Spineart SA | 2026-07-29 |
| NAMIC Dilator and Sheath (K253526) | Medline Industries, LP | 2026-07-29 |
| Stone Clear (BWSC-LP9-02) (K262200) | Sonomotion, Inc. | 2026-07-29 |
| CraniUS Plate (K261058) | CraniUS, LLC | 2026-07-29 |
| CaRi-Heart (DEN250042) | Caristo Diagnostics , Ltd. | 2026-07-28 |
| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (K261412) | Samsung Medison Co., Ltd. | 2026-07-28 |
| Revi System (K253651) | Bluewind Medical , Ltd. | 2026-07-28 |
| uMI Panvivo (uMI Panvivo M) (K261427) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 |
| ELISIO™-HX (K261399) | Nipro Medical Corporation | 2026-07-28 |
| Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326) | Datex-Ohmeda, Inc. | 2026-07-28 |
| TruLift Expandable System (K261430) | Life Spine, Inc. | 2026-07-28 |
| Xpert Ankle (K261511) | Newclip Technics | 2026-07-28 |
| See-Mode Augmented Reporting Tool, Breast (SMART-B) (K260303) | See-Mode Technologies Pty, Ltd. | 2026-07-28 |
| Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K260558) | Hartalega NGC Sdn. Bhd. | 2026-07-28 |
| Air Compression Massager (HY-1165) (K260529) | Xiamen High Top Electronic Technology Co., Ltd. | 2026-07-27 |
| Powered Aventus Thrombectomy System™ (K261105) | Inquis Medical | 2026-07-27 |
| Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211) | Philips Ultrasound, LLC | 2026-07-27 |
| FlexTract Deflectable-Rotational Dilator Sheath Set (K261310) | Merit Medical Systems, Inc. | 2026-07-27 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K262201) | Shockwave Medical, Inc. | 2026-07-27 |
| Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) (K250419) | Plus EV Holdings, Inc. D/B/A Intimate Rose | 2026-07-27 |
| ND Needle Guidance System (K262474) | Accurate Access, LLC | 2026-07-27 |
| ARCHIMEDES Biodegradable Stent (Medium) (K260835) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 |
| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
| CorVista System® with PCWP Add-On (K253576) | Analytics For Life, Inc. | 2026-07-26 |
| Corsano CardioWatch 287-2 System (K261367) | Corsano Health B.V. | 2026-07-26 |
| MONARCH™ Platform (MON-000008) (K260382) | Auris Health, Inc. | 2026-07-25 |
| METICULY Patient-specific CMF solution (K253206) | Meticuly Co., Ltd. | 2026-07-25 |
| DIANA (K260192) | ROPCA ApS | 2026-07-24 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| LumenCare Azure (K262383) | Nucletron B.V. | 2026-07-24 |
| GEN 4 JOY Wheelchair (K252370) | Free Wheelchair Mission | 2026-07-24 |
| REMEDY POLY+PLUS SNAP FIT Acetabular Cup (K262290) | Osteoremedies, LLC | 2026-07-24 |
| Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 (K261781) | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 |
| Accuro® 3S Needle Guide Kit (K261014) | Rivanna Medical, Inc. | 2026-07-24 |
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |
| Careflux H60;Careflux H70;Careflux V500 (K261267) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 |
| PerfusiX-Imaging (K254180) | LIMIS Development B.V. | 2026-07-24 |
| EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (K261274) | Cook Ireland, Ltd. | 2026-07-24 |
| Tiger 2 System (K253943) | Zavation Medical Products, LLC | 2026-07-24 |
| Accuro 3S (K253452) | Rivanna Medical, Inc. | 2026-07-24 |
| EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541) | Medical Impact | 2026-07-24 |
| QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362) | MANTIZ Co., Ltd. | 2026-07-24 |
| Air Compression Massager (EP30B001 I) (K260948) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 2026-07-24 |
| VERAFEYE Imaging Catheter (VF-VIC-002) (K261849) | Luma Vision Limited | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| 5 Wavelength LED Facemask (TN2508) (K260598) | iSMART Developments, Ltd. | 2026-07-24 |
| SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K261221) | Olympus Surgical Technologies America | 2026-07-24 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| TMINI Miniature Robotic System (K261024) | THINK Surgical, Inc. | 2026-07-24 |
| SwiftMR (K261349) | Airs Medical, Inc. | 2026-07-24 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut (K261027) | Hycor Biomedical | 2026-07-24 |
| VS-370CF, VS-370CT (K262152) | VISION MEDICAL Co., Ltd. | 2026-07-24 |
| Ion-L Navigated Instruments (K262121) | SurGenTec, LLC | 2026-07-24 |
| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
| DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (K260259) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 |
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K253277) | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 |
| RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703) | Deka R&D Corp | 2026-07-24 |
| dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (K262294) | Philips Medical Systems Nederland B.V. | 2026-07-24 |
| Gepotidacin GEP 10 µg (K261853) | Liofilchem, Inc. | 2026-07-23 |
| Klassic Infection Spacer System (K261734) | Total Joint Orthopedics, Inc. | 2026-07-23 |
| Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081) | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| FACEGYM Pro Device (HD-109) (K253932) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 |
| Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (K261082) | Microlife Corporation | 2026-07-23 |
| VELMENI for DENTISTS (V4D) 3D (K254096) | Velmeni, Inc. | 2026-07-23 |
| Total Flow Medical Femoral Arterial (TFA) cannula (K251576) | Total Flow Medical Limited | 2026-07-23 |
| Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) (K261136) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 |
| TRUE METRIX Self Monitoring Blood Glucose System (K262116) | Trividia Health, Inc. | 2026-07-23 |
| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| Perfadex Plus (K261644) | Xvivo Perfusion AB | 2026-07-23 |
| 3d Cage Cervical (K253041) | Fims Co., Ltd. | 2026-07-23 |
| CORE 300 Digital Stethoscope (K261694) | Eko Health, Inc. | 2026-07-23 |
| Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 |
| ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272) | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 |
| Tornier Perform Advanced Glenoid (K260721) | Tornier, Inc. | 2026-07-22 |
| Ossiclear (Ossiclear System) (K254296) | Sounduct | 2026-07-22 |
| STEDI Scan Device (K253840) | Stroke DX | 2026-07-22 |
| PreludeSYNC™ Radial Compression Device (K262086) | Merit Medical Systems, Inc. | 2026-07-22 |
| E3D™-C Interbody System (K262094) | Evolution Spine | 2026-07-22 |
| Lancet (K262211) | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 |
| NanoZoomer S540MD Slide Scanner System (K260964) | Hamamatsu Photonics K.K. | 2026-07-22 |
| Lapidus Screw Kit (K262075) | Relja Innovations, LLC | 2026-07-22 |
| Op.n™ Spine Navigation and Robotic Guidance (K261113) | Ecential Robotics | 2026-07-22 |
| Anovo Surgical System (6Ne) (K260804) | Momentis Surgical , Ltd. | 2026-07-22 |
| AlphaTriPart - Monopolar MIC Instruments (K261179) | Gimmi GmbH | 2026-07-22 |
| Medical Thulium Fiber Laser Systems (UroFiber 150Q) (K261738) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| Raney Clips Kit (K253814) | Beijing Honghugaoxiang Science and Technology Development CO | 2026-07-21 |
| One-Fil LC (K261728) | Mediclus Co., Ltd. | 2026-07-21 |
| Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) (K261775) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026-07-21 |
| OTTAVA™ Robotic Surgical System (DEN250068) | Auris Health, Inc., part of Johnson & Johnson MedTech | 2026-07-21 |
| PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves (K262014) | O&M Halyard, Inc. | 2026-07-21 |
| NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut (K260591) | Hycor Biomedical | 2026-07-21 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Versalock Proximal Tibial Plating System (K261406) | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| Thunderbolt System (K261632) | Responsive Arthroscopy, Inc. | 2026-07-20 |
| BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516) | MacroLux Medical Technology Co., Ltd. | 2026-07-20 |