FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253717 | Helo™ Return | Endovascular Engineering, Inc. | Oct 11, 2026 |
| K263154 | CarboClear® Cervical Navigated Instruments | CarboFix Orhtopedics , Ltd. | Oct 9, 2026 |
| K262902 | ECHELON Synergy | Fujifilm Corporation | Oct 9, 2026 |
| K262834 | Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Oct 9, 2026 |
| K262352 | IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Oct 9, 2026 |
| K262301 | Rapid ICH (v4.0) | Ischemaview, Inc. | Oct 9, 2026 |
| K262090 | Fertilis microICSI Device | Fertilis Pty, Ltd. | Oct 9, 2026 |
| K262068 | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) | CathRx, Ltd. | Oct 9, 2026 |
| K261649 | Excelsior Reach Microcatheter | Stryker Neurovascular | Oct 9, 2026 |
| K261521 | Sleep Analysis Module | Neurotronics, LLC | Oct 9, 2026 |
| K261234 | The D-Tip Denudation Pipette | Allwin Medical Devices, Inc. | Oct 9, 2026 |
| K260913 | CMF Titanium Splints | Materialise NV | Oct 9, 2026 |
| K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. | Vivachek Biotech (Hangzhou) Co., Ltd. | Oct 9, 2026 |
| K260156 | TruVision Single-Use 1.9mm Arthroscopy System | Nexus CMF, LLC | Oct 9, 2026 |
| K260096 | Wishbone HAE | Wishbone SA | Oct 9, 2026 |
| K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | Medical Components, Inc. | Oct 9, 2026 |
| P160021S051 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Oct 8, 2026 |
| K263680 | One Coat Bond; One Coat Bond SL | Dent4You AG | Oct 8, 2026 |
| K263150 | V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Oct 8, 2026 |
| K262346 | CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) | Wuhan Phomed Technology Co., Ltd. | Oct 8, 2026 |
| K262244 | Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328) | Stryker Instruments | Oct 8, 2026 |
| K261805 | NEXT-Cue | Neuroxt, Inc. | Oct 8, 2026 |
| K261617 | Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 8, 2026 |
| K260426 | MeCare Alpha (MCA2019) | IVT Medical, Ltd. | Oct 8, 2026 |
| K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments | Centinel Spine, LLC | Oct 7, 2026 |
| K262822 | Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) | Zhongshan GL Electronics Co. , Ltd. | Oct 7, 2026 |
| K262378 | Dr.AlignNavi | InnoDtech, Inc. | Oct 7, 2026 |
| K262368 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | Oct 7, 2026 |
| K262134 | NeuroDR | Deep Reasoning Ai, Inc. | Oct 7, 2026 |
| K261733 | Ligence Heart | UAB Ligence | Oct 7, 2026 |
