Use Advanced Searching to search for a particular word or phrase in a particular indexing field.
Use caution! Not all fields are available for all records.
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.
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
FDA-assigned code corresponding to the classification name.
FDA-assigned premarket approval number presented with initial P followed by
six digits e.g. P950702
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.
Date of approval or substantial equivalence declaration. Entered in the format
Trade (Brand) name(s) for drug(s) discussed in the document.
Generic name(s) for drug(s) discussed in the document.
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
FDA-Assigned docket management code, presented as a hyphenated number e.g. 99P-0100
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
FDA-Assigned petition management code, presented as a hyphenated number e.g. 98P-0102
Government assigned contract or grant number.
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.