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 |
|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | Aug 28, 2026 |
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | Aug 28, 2026 |
| K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | Aug 28, 2026 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | Aug 28, 2026 |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Aug 28, 2026 |
| K261378 | Rayvolve AZchest | AZmed | Aug 28, 2026 |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | Aug 28, 2026 |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | Aug 28, 2026 |
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | Aug 28, 2026 |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | Aug 28, 2026 |
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | Aug 28, 2026 |
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | Aug 28, 2026 |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. | Aug 28, 2026 |
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | Aug 28, 2026 |
| K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Aug 28, 2026 |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | Aug 28, 2026 |
| K262744 | GenesisX RMN | Stereotaxis, Inc. | Aug 27, 2026 |
| K262677 | Iconix Knotless T | Riverpoint Medical | Aug 27, 2026 |
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | Aug 27, 2026 |
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | Aug 27, 2026 |
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | Aug 27, 2026 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Aug 27, 2026 |
| K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | Aug 27, 2026 |
| K261360 | EasyCare Tx 2 | Resmed Corp | Aug 27, 2026 |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | Aug 27, 2026 |
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | Aug 27, 2026 |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | Aug 27, 2026 |
| K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | Aug 27, 2026 |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | Aug 27, 2026 |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | Aug 27, 2026 |
