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Premarket Notifications (510(k)s) recent views
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or... -
Product Classification recent views
This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to... -
Plainview Milk Cooperative Ingredient Recall recent views
This list includes products subject to recall in the United States since June 2009 related to products manufactured by Plainview Milk Products Cooperative. -
Harmful and Potentially Harmful Constituents recent views
The FDA shall publish in a format that is understandable and not misleading to a lay person, and place on public display, a list of 93 harmful and potentially harmful... -
Premarket Approvals (PMA) recent views
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved... -
FDA Abbott Infant Formula Recall recent views
On September 22, 2010, Abbott issued a voluntary recall of certain Similac powdered infant formula after identifying a common warehouse beetle (both larvae and adults) in the... -
MAUDE (Manufacturer and User Facility Device Experience) recent views
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991,... -
CDRH Advisory Meeting Materials Archive recent views
This database contains historical information about CDRH Advisory Committees and Panel meetings through 2008, including summaries and transcripts. -
CDRH Inspections Database recent views
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present. -
MedWatch Safety Alerts for Human Medical Products recent views
MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain... -
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book) recent views
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of... -
Warning Letters recent views
An index of FDA warning letters issued to companies operating in the United States. -
Current and Resolved Drug Shortages and Discontinuations Reported to FDA recent views
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
Inspection Database recent views
FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not intended to... -
FDA Pet Health and Safety Widget recent views
Contains data for FDA pet food recalls since January 1, 2006. -
Drugs to be Discontinued recent views
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act)... -
MedSun Reports recent views
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the clinical... -
Post-Approval Studies recent views
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket... -
Abbott Infant Formula Recall recent views
This list includes products subject to recall since September 2010 related to infant formula distributed by Abbott. This list will be updated with publicly available information... -
Establishment Registration & Device Listing recent views
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for...
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