Medical Device Listing 501k

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510(k) Clearances | FDA

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

510 (k) Clearances Overview Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at...

Search Registration and Listing | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/search-registration-and-listing

Search the Registration & Listing database Establishment Registration and Medical Device Listing Files for Download Releasable establishment registration and listing information …

Premarket Notification 510(k) | FDA

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

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution …

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) …

510(k) Premarket Notification - Food and Drug …

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

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 …

510(k) Forms | FDA

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

510 (k) "Substantial Equivalence" Decision Making Process (PDF - 844KB) Indications for Use (PDF - 1.7MB) Required Elements for a Declaration of …

Medical Device Exemptions 510(k) and GMP Requirements

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

clinical chemistry and clinical toxicology devices: part 864: hematology and pathology devices: part 866: immunology and microbiology devices: part 868: anesthesiology …

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