Establishment Registration & Device Listing - Food and Drug …
Feb 3, 2025 · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. You can enter a premarket submission number, a company name, registration or owner/operator number to search for registration and listing information.
510(k) Premarket Notification - Food and Drug Administration
Feb 3, 2025 · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
MDR Database Search - Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA
Manufacturer and User Facility Device Experience (MAUDE) Database
Jan 31, 2025 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
Product Classification - Food and Drug Administration
2 days ago · a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Learn More...
pregnant women to inform a drug-associated risk. Animal reproductive and developmental toxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved Medication Guide. Revised: 12/2024 . Reference ID: 5501094
For current labeling information, please visit https://www.fda.gov/drugsatfda Instructions for delivering the dosage are provided in the Instructions for Use leaflets enclosed with the RIVFLOZA Pre-filled Syringe and single-dose vial.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2024 . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . 2.1 Patient Selection . 2.2 Recommended Testing and Advice Prior to Initiating ENSACOVE . 2.3 Recommended Dosage . 2.4 Dosage …
than one drug to achieve BP goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).