Pricing

$0.30 / 1,000 decisions

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FDA Device 510(k) Clearances & PMA Approvals

Try for free

Every FDA medical device 510(k) clearance and PMA approval or supplement from openFDA. Filter by company, product code, device name, review panel and decision date. Decision and receipt dates on every row.

Pricing

$0.30 / 1,000 decisions

Rating

0.0

(0)

Developer

Pushbuild Data

Actor stats

Bookmarked

Total users

Monthly active users

2 days ago

Last modified

Categories

Business

Other

Dataset

dataset

Optional

Which decisions to return.

Type:string

Default:both

Options:

both510kpma

Company (applicant)

applicant

Optional

e.g. Medtronic, Boston Scientific.

Type:string

Device name contains

deviceName

Optional

Matches the device, trade or generic name.

Type:string

FDA product codes

productCodes

Optional

Three-letter product codes, e.g. QAS (radiology triage software).

Type:array

Review panel code

advisoryCommittee

Optional

Two-letter code, e.g. CV (cardiovascular), RA (radiology), OR (orthopedic).

Type:string

510(k) decision code

decisionCode

Optional

e.g. SESE (substantially equivalent). 510(k) only.

Type:string

Original PMAs only

originalPmaOnly

Optional

Skip PMA supplements and 30-day notices.

Type:boolean

Default:false

Decision date from

dateFrom

Optional

YYYY-MM-DD. Default: 30 days ago.

Type:string

Decision date to

dateTo

Optional

YYYY-MM-DD. Default: today.

Type:string

Sort

sort

Optional

By decision date.

Type:string

Default:newest

Options:

newestoldest

Max results

maxItems

Optional

Maximum rows returned.

Type:integer

Minimum:1

Maximum:100000

Default:1000

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