510(k) approval games played by medical instrument manufacturers.

Days before a Netflix documentary"The bleeding  edge" about it drops—manufacturer Bayer announced it will stop selling the controversial implant. The company framed its decision as based on poor sales, but the timing is hard to ignore: The Bleeding Edge, a documentary about medical devices gone awry that uses Essure as a prime example, drops on July 27. Essure was pulled July 20.
let us look at our own Indian story about Johnson & Johnson subsidiary Depuy International LTD.

According to the report of a committee set up to investigate the matter, in 2006, DePuy International Limited or J&J registered its orthopaedic implants (ASR XL Acetabular hip system and ASR hip resurfacing system) with Indian drug regulators for import on the basis of the 510(k) approval. It implies that the regulators approved the ASR XL Acetabular hip system about two years before it was approved in the US.

DCGI (Drug Controller General of India) guidelines for medical device approval began in the year 2006, before Which there were no guidelines from DCGI for approval of medical devices. 
Accordingly, in 2006, the ASR hip system was approved by the DCGI for
marketing in India. It already was being sold in India with no need for approvals since 2004.
The distributor also admitted that at the time of filing of a criminal case (No. 
435/2011 on November 19, 2011) and its investigation thereafter, the device was still being sold. Only 64 devices were unsold by then, which were 
returned to the company. 
However, in its response dated December 23, 201,0 to the drug controller, the 
company said that the entire stock of faulty implants available in the market 
till September 2010 had been taken back and the recall process had been 
completed. This means the devices were sold in the country even after the 
company claimed otherwise. 
The company has denied this, saying it did not further sell any ASR products 
to any dealer or hospital after the voluntary recall notice was issued on 24 
August 2010. DePuy recalled the unused stocks of ASR devices from the 

market...." 

"Further, the CDSCO and the DCGI turned down a Right to Information request by Mukesh Jain, an ASR hip implant patient, on December 26, 2014, seeking documents submitted by J&J/DePuy related to the import licence. The applicant claimed misuse of power under section 11(1) by the Central Public Information Officer and challenged the regulator's attempt to withhold related information. The company referred to these documents as proprietary and turned down request to access them."

(Question 
Are all documents submitted to Indian Govt  regulators by  companies subject to  Right to Information requests)