510k Medical Products

Search the Releasable 510(k) Database | FDA

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

You 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: Device...

510(k) Devices Cleared in 2022 | FDA

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

510 (k) Devices Cleared in 2022 | FDA Home Medical Devices Products and Medical Procedures Device Approvals, Denials and Clearances 510 (k) Clearances 510 (k) …

Premarket Notification 510(k) | FDA

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

Content of a 510(k) | FDA - U.S. Food and Drug …

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

The first page of a 510 (k) should be a printed copy of the Medical Device User Fee Cover Sheet (Form FDA 3601). The Medical Device User Fee Cover Sheet and instructions are …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …

510(k) Frequently Asked Questions | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-frequently-asked-questions

510 (k) Frequently Asked Questions Distributors Foreign Manufacturers Registration Quality System Distributors I would like to distribute a manufacturer's product under my own …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=DPS&KNumber=&Applicant=PHILIPS%20MEDICAL%20SYSTEMS&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=02%2F18%2F2023&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=dn_asc

Tobacco Products . 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 1 to 10 of 15 Results ProductCode: DPS Applicant: PHILIPS MEDICAL …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=DPS&KNumber=&Applicant=PHILIPS%20MEDICAL%20SYSTEMS&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=02%2F18%2F2023&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=dn_desc

Tobacco Products . 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 1 to 10 of 15 Results ProductCode: DPS Applicant: PHILIPS MEDICAL …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=DPS&KNumber=&Applicant=PHILIPS%20MEDICAL%20SYSTEMS&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=02%2F18%2F2023&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=dd_desc

Tobacco Products . 510(k) Premarket Notification. FDA Home; ... Databases - 1 to 10 of 15 Results ProductCode: DPS Applicant: PHILIPS MEDICAL SYSTEMS Decision Date To: …