Blogs about: 510k Process

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DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

Trial plaintiff says J&J hips defective, company says not liable. Trial plaintiff says J&J hips defective, company says not liable 3/1/2013 By Deena Beasley (Reuters) – Johnson & Joh… more →

Earl's View

"Considering a Mesh Implant? You have better odds playing Russian roulette"

DebCNY wrote 2 weeks ago: That was the title of the poster created by Jaye Lee,  who also suffers from mesh complications ( … more →

Tags: FDA, Mesh Complications, Pelvic Organ Prolapse, Alternatives, alternatives to using mesh, American Urogynecologic Society, AUGS, Ban, FDA Warnings

Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI — 10 comments

DebCNY wrote 1 month ago: What if I could go back in time to before I had my mesh implant for SUI? What are the things I wish … more →

Tags: FDA, Feature, Mesh Complications, Mesh for SUI vs POP, 510k, Alternatives, bladder prolapse, Bladder Sling, FDA Warnings

DePuy ASR Trial - Closing Arguments - Trial plaintiff says J&J hips defective, company says not liable — 6 comments

earlstevens58 wrote 2 months ago: Trial plaintiff says J&J hips defective, company says not liable. Trial plaintiff says J&J h … more →

Tags: Cobalt-Chrome, Cobalt poisoning, cobaltism, DePuy ASR Hip, DePuy Hip Litigation, hip replacement, Hip Revisions, Johnson & Johnson, metal on metal hip

DePuy Trial Continues Despite Talks of Settlement - Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts — 5 comments

earlstevens58 wrote 3 months ago: DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Sea … more →

Tags: Cobalt-Chrome, Cobalt poisoning, cobaltism, DePuy ASR Hip, DePuy Hip Litigation, hip replacement, Hip Revisions, Johnson & Johnson, metal on metal hip

When Doctors Keep Quiet about Dangerous Hip Devices — 16 comments

Allison wrote 3 months ago: A doctor’s note to Johnson & Johnson (J&J) executives criticizing their marketing of a dange … more →

Tags: depuy, DePuy ASR Hip, DePuy Doctor Kickback, DePuy Hip Litigation, depuy hip recall, depuy hip replacement recall, depuy lawsuit, Johnson & Johnson, Johnson & Johnson lawsuit

NEJM Article about 510(k) Ancestry Reveals Problems with Metal Hip Implants

Allison wrote 3 months ago: The national law firm of Anapol Schwartz applauds New England Journal of Medicine’s (NEJM) rec … more →

Tags: DePuy ASR Hip, DePuy Hip Replacement, FDA 510k process

Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation - Forbes — 1 comment

earlstevens58 wrote 4 months ago: Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, C … more →

Tags: FDA, FDA 510k process, FDA Approval of Hip and Knee Implants, Arrest, Beth Israel Deaconess Medical Center, Current Events, food & drug administration, Forbes, Government

Not actually tested - The 510(k) Ancestry of a Metal-on-Metal Hip Implant

ISOwatcher wrote 4 months ago: In recent years, metal on metal hip replacements have been causing problems, depositing worn-off met … more →

Tags: Science, Practical Problems, Medicine, laboratory medicine, Food and Drug Administration (FDA), SI Units, traceability, NEJM, Great Chain of Being

FDA 510(k) Seminar | Jan 14, 2013 | 510(k): Preparation, Submission, and Clearance | Global Compliance Seminar

Dr. David Lim, Ph.D., RAC, ASQ-CQA wrote 4 months ago: FDA 510(k) Seminar | Jan 14, 2013 | 510(k): Preparation, Submission, and Clearance FDA 510(k) LIVE O … more →

Tags: 510k, 510(k) LIVE Seminar | Webinar, FDA, Regulatory Doctor

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

David Lim | Regulatory Doctor | 510(k) wrote 4 months ago: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Many medical devices that pose great safety risk … more →

Tags: 510k, FDA, safety and effectiveness, hip implant, metal on metal hip implant

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

Dr. David Lim, Ph.D., RAC, ASQ-CQA wrote 4 months ago: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Many medical devices that pose great safety risk … more →

Tags: FDA, 510k, Metal on Metal Hip Implants

26% Failure in Female Smith & Nephew BHR's - The ten-year survival of the Birmingham... [J Bone Joint Surg Br. 2012] - PubMed - NCBI — 11 comments

earlstevens58 wrote 8 months ago: 26% Failure in Female Smith & Nephew BHR’s – and higher failure in older males … more →

Tags: Birmingham Hip Resurfacing, Smith & Nephew, Smith & Nephew BHR Problems, Birmingham, food & drug administration, Hip Resurfacing, Journal of Bone and Joint Surgery, Medicine, NephewSmith

FDA Aims To Smooth Premarket Review process | Bloomberg BNA — 2 comments

earlstevens58 wrote 9 months ago: FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To … more →

Tags: FDA, FDA 510k process, Business, Center for Devices and Radiological Health, draft guidances, Federal Food Drug and Cosmetic Act, food & drug administration, Medical device, PMA

FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists — 3 comments

earlstevens58 wrote 9 months ago: FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan t … more →

Tags: FDA Review, FDA Spying, Chuck Grassley, FDA, Food and Drug Administration, Government, Internet, National Whistleblowers Center, Politics

Dems urge FDA to boost medtech recall database | MassDevice.com — 4 comments

earlstevens58 wrote 9 months ago: Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical … more →

Tags: FDA, FDA 510k process, Dangerous Loophole, Database, Ed Markey, Federal Food Drug and Cosmetic Act, food & drug administration, jeffrey shuren, Massachusetts

Loophole in FDA's Approval Process for Medical Devices Prompts Letter from Congress - Forbes — 8 comments

earlstevens58 wrote 9 months ago: Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Fo … more →

Tags: FDA, FDA 510k process, Center for Devices and Radiological Health, Congress, Ed Markey, edward markey, Federal Food Drug and Cosmetic Act, food & drug administration, Internet

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno — 7 comments

earlstevens58 wrote 9 months ago: Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement … more →

Tags: Birmingham Hip Resurfacing, FDA, FDA 510k process, FDA Approval of Hip and Knee Implants, FDA recall, FDA Review, Hip Resurfacing, metal on metal hip, Metallosis

FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers — 1 comment

earlstevens58 wrote 9 months ago: FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employe … more →

Tags: FDA, FDA 510k process, FDA Review, FDA Spying, FDA Warning, Barack Obama, Chris Van Hollen, Food and Drug Administration, New York Time

What does the FDA have to Hide? Who do they work for?? — 4 comments

earlstevens58 wrote 9 months ago: FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spy … more →

Tags: FDA, FDA 510k process, Congress, Employment, Food and Drug Administration, united states congress, United States Office of Special Counsel, Whistleblower, White House


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