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Earl's View

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Earl's View

Tag Archives: Medical device

Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA

July 7, 2012

Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …

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Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

July 7, 2012

MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …

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P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices

July 7, 2012

P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …

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Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL

July 7, 2012

Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help Victims Of Defective Drugs Or Medical Devices – SFGate

July 1, 2012

The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help …

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Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act

June 30, 2012

Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …

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Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA

June 26, 2012

MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Contact: Press Office 020 3080 …

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FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew

June 17, 2012

Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …

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Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

June 5, 2012

I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …

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Thanks from Howard

June 3, 2012

Thank you Earl and your blog again and thank you  folks that have contacted me re: attorneys. I will let …

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FDA rule clears medical devices without human testing | devices, – News – The Orange County Register

May 24, 2012

FDA rule clears medical devices without human testing | devices, – News – The Orange County Register. Published: May 18, …

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Zimmer Durom Cup Hip Implant – Waters & Kraus

May 24, 2012

Zimmer Durom Cup Hip Implant – Waters & Kraus. Zimmer Durom Cup Hip Implant We protect the interests of those …

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Statute of Limitations Looming for DePuy Hip Implant Lawsuits

May 24, 2012

Statute of Limitations Looming for DePuy Hip Implant Lawsuits. Statute of Limitations Looming for DePuy Hip Implant Lawsuits Monday, 21 …

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Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant

May 24, 2012

Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant. Are Metal-on-Metal …

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Howard poses some important questions….

May 24, 2012

I am looking for a real answer to a real question- if the Catholic Church was held accountable for their …

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Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics

May 22, 2012

Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year  Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …

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Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders to Step Forward for Possible Huge Rewards

May 13, 2012

Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders …

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German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry News

May 13, 2012

German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry …

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Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry

May 12, 2012

Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry. The global medical crises of dangerous metal-on-metal hip implants …

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Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public

May 12, 2012

Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public. Public Communication – Health Canada Issued Important Safety Information …

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Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG

May 12, 2012

Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …

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MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee

May 1, 2012

I just want to emphasize how important it is for as many of us as possible to send in our …

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June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 27, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …

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Howard shares more views

April 25, 2012

Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …

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What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs

March 24, 2012

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …

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Senators Introduce Safe Medical Devices Act

March 24, 2012

Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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Consumer Reports Poll: Consumers Support More Medical Device Oversight

March 21, 2012

Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE     …

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House of Representatives to take away Patients rights to Sue

March 18, 2012

March 16, 2012 Next week, the U.S. House of Representatives will be voting on H.R. No. 5, which has been …

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US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and the DePuy ASR was Just the Starting Point – Yahoo! News

March 3, 2012

US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and …

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Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA

March 1, 2012

Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA. Press release: MHRA updates advice for metal-on-metal hip replacements …

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Mark’s Story – another Smith & Nephew BHR disaster – 18 Months

January 26, 2012

Yesterday I was told the total hip resurfacing Smith and Nephew I received 9/2010 must be removed. They are doing …

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The Power of the Birmingham Hip Resurfacing – NOT

January 21, 2012

Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …

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FDA warns J&J’s DePuy unit over joint replacements – AlertNet

January 19, 2012

FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …

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More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems

January 14, 2012

Correspondence from an “in pain and damaged BHR recipient” To: [deleted doctors name] Biosciences & Implants Unit Medical Devices Division …

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Mesh Medical Device Newsdesk

January 8, 2012

Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something …

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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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More Smith & Nephew BHR Problems

January 2, 2012

More Smith & Nephew BHR – MoM Problems Emerging each day Comment received overnight: I too have a Smith and …

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Howard View – on a few things

December 30, 2011

Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …

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FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline

December 29, 2011

Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …

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Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record

December 28, 2011

Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record. Zimmer knee replacement manufacturer sued for metal …

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Howard’s View – Get Your Health Right is Number One Priority

December 28, 2011

More and more people are sharing their stories of suffering because of this hip debacle. This is great, let’s others …

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The regulatory standards for the approval of medical devices in Australia – Senate Inquiry

December 25, 2011

The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Howard Sdwin: What isn’t being published is the truth regarding the medical device world

December 17, 2011

What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …

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San Francisco Personal Injury Attorney Analyzes Depuy Lawsuits And Preemption

November 26, 2011

San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption. DePuy Hip Implant Claims & Federal Preemption November 23, 2011 …

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