Company Name:
Contains the name of the company discussed in the document. Generally, only significant portions of the company name are included; do not include terms like "Inc." or "Co." in your search. For clinical investigator EIRs, this field includes the name of the clinical investigator.

K Number:
FDA-assigned device 510(k) number presented with initial K followed by six digits e.g. K990709 Biologic 510(k)s are presented with an initial BK followed by six digits.

Device Code:
FDA-assigned code corresponding to the classification name.

PMA Number:
FDA-assigned premarket approval number presented with initial P followed by six digits e.g. P950702

NDA Number:
This field includes the Drug Application Number, when known. NDA and ANDA numbers are entered with an initial N followed by five digits e.g. NDA #20-262 is searched as N20262. Veterinary application numbers begin with V; Biologic application numbers begin with B.

Approval Date:
Date of approval or substantial equivalence declaration. Entered in the format mm/dd/yyyy.

Trade Name:
Trade (Brand) name(s) for drug(s) discussed in the document.

Generic Name:
Generic name(s) for drug(s) discussed in the document.

Begin Date:
Used to indicate the beginning of a referenced event, e.g. the beginning date of an inspection or advisory committee meeting. Presented in the format mm/dd/yyyy

Docket Number:
FDA-Assigned docket management code, presented as a hyphenated number e.g. 99P-0100

Recall Number:
FDA-Assigned recall tracking number presented with a leading # sign and internal hyphenation, e.g. #Z-000-2. The letter indicates the product recalled: Z=Device recall; D=Drug recall; B=Biologic recall

Petition Number:
FDA-Assigned petition management code, presented as a hyphenated number e.g. 98P-0102

Contract Number:
Government assigned contract or grant number.

People:
FDA and/or company individuals named in the document, such as FDA investigators involved in an inspection, company representatives speaking at an advisory committee meeting, FDA approval application reviewers.

Advisory Committee Name:
The full name of the advisory committee is included for advisory committee meeting minutes and transcripts. If known, the advisory panel name is included for device approvals and 510(k)s.