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You may be Purchasing an item that may be subject to strict regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Do not purchase any item unless you are licensed to purchase it. We will verify your eligibility to purchase and use this item before completing the transaction by having an FDA form printed and faxed back to us. Click here for this form.
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Please Consult the FDAs Website for more information.

 

MOST ENDOSCOPES HAVE F.D.A. 510K FOR USE IN U.S.A. , ENDOSCOPES WHICH DO NOT HAVE F.D.A. 510K CANNOT BE USED IN THE U.S.A., THEY CAN BE USED BY VETERINARY OR IN COUNTRIES WHICH AUTHORIZE THEIR USE.

TO SEARCH FOR F.D.A. 510K DESIGNATIONS CLICK HERE!

The F.D.A. requires all pre-owned medical equipment sold in the U.S.A. to have O.E.M. Parts. After Purchase for use in the U.S.A., send your equipment into the Manufacturer to be registered and for inspection of your equipment purchase. Have any parts which are non - O.E.M. replaced by the manufacturer for use in the U.S.A..

 

Click here for F.D.A. Manufacturer and User Facility Device Experience:

 

F.D.A. Latest Information on 97N-0477 FDA Regulations; Medical Devices;
Refurbishers, Rebuilder, Reconditioners, Servicers, and "As Is" Remarketers 

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Information on FDA 21CFR 820 801 Medical Device Reporting

 

 

 

RECALLS:

Check for any recalls on any endoscopy equipment at:

www.FDA.gov

*** Recall on Olympus® Bronchoscopes click here!

**** Recall on Pentax® Bronchoscopes click here!

***Recall on Olympus GIF-2T20, 2T100

***Recall on Fujinon Video Colonoscopes EC-200LR,LT

**** Recall on Pentax® Colonoscopes click here!
 (Colonoscope Connecting Receptacle Corrective Action
Ref FDA Recall: Z-1196-1/Z1197-1)

 


Read and Review our legal page before using this site.

We sell New and Used Endoscopes and are not associated or affiliated in any way with; Olympus® Inc., Pentax® Inc., Fujinon® Inc ( FUJIFILM Medical Systems U.S.A.), Machida®, Storz® Inc®. All product names and images on our webpages are trademarks or registered ® trademarks of their respective holders, Including Olympus® Inc
., Pentax® Inc., Fujinon® Inc ( FUJIFILM Medical Systems U.S.A.), Storz® Inc®. **Prices Subject to change without notice. 
 


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*** as reported by www.FDA.gov
**** Pentax® report