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The document is a 510(k) summary for the Flexible Video Cystoscope / Choledochoscope submitted by Richard Wolf Medical Instruments Corporation. It outlines the device's intended use for visualizing body cavities and organs in urology and surgery, its technological characteristics, and claims substantial equivalence to existing devices. The document also includes performance data, regulatory information, and a conclusion affirming the device's safety and effectiveness.

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How to check if a company is FDA approved?

0:28 1:45 Website look for The Establishment registration. And device listing section this is where the magicMoreWebsite look for The Establishment registration. And device listing section this is where the magic happens. But remember youre not looking for a rabbit in a hat youre looking for a company in a

How do I check my FDA approval status?

Look up the drug or biological product in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.

What is the continued access protocol FDA?

Continued Access (Extended Investigation) of an Unapproved Medical Device. FDA may allow continued enrollment of subjects after the clinical trial under an IDE has been completed to allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA.

How do I check the status of my FDA entry?

Q: How do I find out further information regarding the status of my entry or pending FDA exam? A: The most up to date entry status can be viewed via ITACS at . For further information regarding entry status or pending FDA exam contact the FDA office at the Port of Entry.

How do you check if a device is FDA-approved?

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 FDA FOIA?

The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible electronic reading rooms with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

Where can I check my FDA approval status?

To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. The FDA Orange Book contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

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