510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards

Search 510(k) Database Download Files | More About 510(k) 510K Number   Type  Traditional Special Abbreviated Cleared for Marketing Automatic Class III Designation Model Cleared/Approved IVD Products  Applicant Name Expedited Review   Yes No No Data Device Name Third Party Reviewed  Panel Anesthesiology General Hospital Ear Nose & Throat General & Plastic Surgery Immunology Ophthalmic Radiology Cardiovascular Gastroenterology/Urology Microbiology Orthopedic Clinical Chemistry Neurology Pathology Toxicology Dental Hematology Obstetrics/Gynecology Physical Medicine Product Code   Decision CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT (AN) SE SUBJECT TO TRACKING REG (ST) SE SUBJECT TO TRAKING & PMS (PT) SE WAITING ON FUTURE POLICIES (SF) SE-SPECIAL LABELING (SS) SUBST EQUIV (SE) SUBST EQUIV - AWAITING DEVICE APPROVA (SA) SUBST EQUIV - AWAITING DRUG APPROVAL (SW) SUBST EQUIV - CLIA SUBMISSION (CS) SUBST EQUIV - KIT (SK) SUBST EQUIV - KIT WITH DRUGS (KD) SUBST EQUIV - MARKET AFTER INSPECTION (SI) SUBST EQUIV - POSTMARKET SURVEILLANCE (SP) SUBST EQUIV - WITH LIMITATIONS (SU) SUBST EQUIV FOR SOME INDICATIONS (SN) SUBST EQUIV WITH DRUG (SD) Decision Date   to       Clinical Trials  Sort by Decision Date (descending) Decision Date (ascending) Device Name (A-Z) Device Name (Z-A) Applicant Name (A-Z) Applicant Name (Z-A) 510(k) Number (descending) 510(k) Number (ascending) For full-text search, select Go To Simple Search button     10 25 50 100 500  Records per Report Page