510 k database fda | Search the Releasable 510(k) Database

Keyword	CPC	PCC	Volume	Score	Length of keyword
510 k database fda	0.84	0.6	7223	77	18
510	1.09	0.7	938	67	3
k	1.27	0.2	3050	72	1
database	1.73	1	5588	43	8
fda	0.88	0.8	2949	25	3

Keyword	CPC	PCC	Volume	Score
510 k database fda	1.26	0.5	5827	99
fda 510 k database search	1.39	0.9	1074	87
fda searchable 510 k database	1.61	0.9	6328	69
fda releasable 510 k database	0.57	1	1656	90
us fda 510 k database	0.17	0.8	7178	11
fda 510 k clearance database	1.31	0.1	8811	95
fda 510k database searchable	0.06	0.8	8477	7

Search Results related to 510 k database fda on Search Engine

Search the Releasable 510(k) Database | FDA
fda.gov

https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database

WebYou can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following …

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510(K) Premarket Notification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmnsimplesearch.cfm

WebDatabases 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 …

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Medical Device Databases | FDA
fda.gov

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Web28 rows · Apr 6, 2022 · This database of releasable 510(k)s can be searched by 510(k) …

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Premarket Notification 510(k) | FDA
fda.gov

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

IntroductionWhat Is Substantial EquivalenceWho Is Required to Submit A 510When A 510(k) Is RequiredWhen A 510(k) Is Not RequiredPreamendment DevicesThird Party Review ProgramAdditional Information The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. The following four categories of parties must submit a 510(k) to the FDA: 1. Domestic manufacturers introducing a device to the U.S. market; F...

The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. The following four categories of parties must submit a 510(k) to the FDA: 1. Domestic manufacturers introducing a device to the U.S. market; F...

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510 (k) Clearances - Food and Drug Administration
fda.gov

https://open.fda.gov/data/510k/

WebA 510 (k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally …

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Downloadable 510(k) Files | FDA
fda.gov

https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files

WebNov 23, 2021 · 510 (k) Clearances Downloadable 510 (k) Files Downloadable 510 (k) Files You can download any of the following zipped files, each of which contains information …

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Content of a 510(k) | FDA
fda.gov

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

WebIntroduction The 510 (k) regulation is found in 21 CFR 807 Subpart E and includes information required in a 510 (k). The 510 (k) is not a form. The information should be provided in an...

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Product Classification - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

WebMay 29, 2023 · Databases This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other …

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510(k) Devices Cleared in 2022 | FDA
fda.gov

https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2022

WebJan 5, 2023 · Home Medical Devices Products and Medical Procedures Device Approvals, Denials and Clearances 510 (k) Clearances 510 (k) Devices Cleared in 2022 510 (k) …

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