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

Keyword	CPC	PCC	Volume	Score	Length of keyword
fda 510k database	0.28	0.4	6546	12	17
fda	1.46	0.3	4452	39	3
510k	1.4	0.4	3163	38	4
database	0.29	0.7	5392	20	8

Keyword	CPC	PCC	Volume	Score
fda 510k database	1.66	0.7	7733	56
fda 510k database search	0.18	0.3	8378	6
fda 510k database searchable	1.59	0.4	5345	2
fda 510k database api	1.88	1	7782	58
fda 510k database csv	0.71	0.2	7348	43
fda 510k database excel	0.55	0.9	2493	17
fda 510k database query	0.42	0.1	7610	49
fda 510k database access	0.04	0.2	8185	32
fda 510k database summary	1.55	0.8	8841	45
fda 510k database download	0.77	0.9	8236	39
fda 510k database statistics	0.66	0.8	2416	24
us fda 510k database	1.69	0.8	3959	33
fda medical device database 510k	0.62	0.6	2735	26

Search Results related to fda 510k database 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 format:...

DA: 4 PA: 83 MOZ Rank: 65

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

WEB3 days ago · FDA Home. Medical Devices. Databases. 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...

DA: 96 PA: 34 MOZ Rank: 18

510(k) Clearances | FDA - U.S. Food and Drug Administration
fda.gov

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

WEBAug 31, 2021 · Search the Releasable 510(k) Database; 510(k) Devices Cleared in 2023; 510(k) Devices Cleared in 2022; 510(k) Devices Cleared in 2021; 510(k) Devices Cleared in 2020;...

DA: 69 PA: 88 MOZ Rank: 50

510(k) Clearances | FDA - U.S. Food and Drug Administration
fda.gov

https://www.fda.gov/medical-devices/device-approvals-and-clearances/510k-clearances

WEBNov 6, 2023 · Browse and Search for 510(k) Clearances. Search the 510(k) Premarket Notification database. Browse for Clearances by Year. 510(k) Devices Cleared in 2023; 510(k) Devices Cleared...

DA: 69 PA: 27 MOZ Rank: 12

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

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

WEB510(K) Number. Decision Date. t:slim x2 insulin pump with interoperable technology: Tandem Diabetes Care, Inc. den180058: 02/14/2019: cell-free dna bct: Streck, Inc. den200001: 08/07/2020: single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: next step powder free latex examination gloves contains 50 mcgm or less of …

DA: 47 PA: 20 MOZ Rank: 97

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 marketed device that is not subject to premarket approval (PMA). 510 (k) (premarket notification) to FDA is required at least 90 days before marketing unless the device ...

DA: 28 PA: 12 MOZ Rank: 56

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

https://open.fda.gov/apis/device/510k/

WEBThe openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates.

DA: 62 PA: 12 MOZ Rank: 78

Medical Device Databases | FDA
fda.gov

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

WEBThis database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

DA: 70 PA: 33 MOZ Rank: 65

Premarket Approval (PMA) - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

WEBApr 8, 2024 · Databases. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable …

DA: 47 PA: 81 MOZ Rank: 4

A Closer Look at the 510(k) Pathway: What Employers Should Know
businessgrouphealth.org

https://www.businessgrouphealth.org/en/resources/510k%20pathway

WEBMarch 24, 2022. In 2021 alone, the U.S. Food and Drug Administration (FDA) cleared nearly 3,000 “medical devices” through the 510 (k) pathway. 1 Employers are increasingly paying attention to the potential pitfalls of this pathway, as it can be a vehicle for certain drug-like products to come to market without having undergone a formal and ...

DA: 39 PA: 71 MOZ Rank: 8