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FDA Product Data Sheet: Medical Devices Account NumberAccount NameDUNS Number (if available)Client Part Number*Description of Product (as complete as possible) Government Agency Processing CodeTariff.

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You may search for a legally marketed device's product classification by reviewing its device listing information. Device listing information can be found by searching the FDA's Establishment Registration and Device Listing database, using either the Quick or Advanced Search feature.

Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998.

The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission.

Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA. To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database.

What is an FDA product code? An FDA product code describes a specific product and contains a combination of five to seven numbers and letters. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product.

https://.fda.gov/Medical-Devices.

Medical Devices Cleared or Approved by FDA in 2021 Device NameCategoryOrgan Care System (OCS) Heart System - P180051TransplantRADIESSE (+) Lidocaine Injectable Implant - P050052/S129ImplantOncomine Dx Target Test - P160045/S028Laboratory TestVENTANA MMR RxDx Panel - P210001Laboratory Test21 more rows

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232