Name: FDA Device 510(k) Clearances
Creator: ModernRelay

FDA Device 510(k) Clearances

FDA 510(k) clearance decisions for medical devices, showing which devices were cleared for market, the companies that applied, device types, and how they compare to existing approved devices

510(k) Clearances Data

510(k) Clearances records
K Number	Address Line 1	Advisory Committee	Advisory Committee Description	Applicant	City	Clearance Type	Contact	Country Code
DEN000001	P.O. Box 7550	AN	Anesthesiology	Ohmeda Medical	Madison	Post-NSE	DANIEL KOSEDNAR	US
DEN000002	2660 Crosspark Rd.	GU	Gastroenterology, Urology	Urosurge, Inc.	Coralville	Post-NSE	STEVEN J PREISS	US
DEN000004	4215 Renoak Court	AN	Anesthesiology	Maet Industries, Inc.	Mississauga, Ontario	Post-NSE	WAYNE WITBECK	CA
DEN000006	445 Etna St., Suite 56

	K Number	Address Line 1	Address Line 2	Advisory Committee	Advisory Committee Description	Applicant	City	Clearance Type	Contact	Country Code	Date Received	Decision Code	Decision Date	Decision Description	Device Class	Device Name	Expedited Review Flag	Medical Specialty Description	OpenFDA Device Name	Postal Code	Product Code	Registration Numbers	Regulation Number	Review Advisory Committee	State	Statement or Summary	Third Party Flag	ZIP Code

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