Navigation Links
Stryker Announces Resolution of Two FDA Warning Letters
Date:5/19/2010

KALAMAZOO, Mich., May 19 /PRNewswire-FirstCall/ -- Stryker Corporation (NYSE: SYK) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the actions undertaken to address issues raised in two Warning Letters received in 2007 and 2009 are sufficient.  

The Company received a Warning Letter from FDA regarding compliance with certain quality system requirements at its reconstructive implant manufacturing facility in Cork, Ireland in 2007. In 2009, the Company received a Warning Letter from FDA related to compliance issues for one of its craniomaxillofacial (CMF) implant products that was previously sold through its CMF distribution facility in Portage, Michigan.  Following FDA re-inspection of the Cork, Ireland facility and additional corrective actions at both the Cork and CMF facilities, the Company has been notified  that issues raised have been adequately addressed and no further formal corrective actions are required.

"We are highly encouraged that the corrective actions undertaken have been positively reviewed by FDA resulting in resolution of the two remaining Warning Letters," said Stephen P. MacMillan, Stryker's Chairman, President and Chief Executive Officer. "We are committed to ongoing investments in our compliance systems and believe this latest news supports the progress we are making in achieving our goals."

About Stryker

Stryker is one of the world's leading medical technology companies and is dedicated to helping hea
'/>"/>

SOURCE Stryker Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Stryker Enters Strategic Marketing Agreement With Intuitive Surgical
2. Stryker Launches New Technologies and Celebrates a Major Clinical Milestone at The American Academy of Orthopaedic Surgeons Conference
3. Stryker to Host Conference Call on April 20, 2010
4. Stryker to Present at Investor Conference
5. Stryker Interventional Spine Launches VertaPlex(R) HV
6. Stryker to Host Analyst Meeting
7. Stryker Corporation Announces Pricing of Senior Notes
8. Stryker Updates Expected 2009 Results and Provides 2010 Outlook
9. Stryker Completes Acquisition of Ascent Healthcare Solutions
10. Stryker Announces $750 Million Share Repurchase Program and Declares a $0.15 Per Share Quarterly Dividend
11. RoundTable Healthcare Partners Announces Sale of Ascent Healthcare Solutions to Stryker Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Trade Commission (ITC) issued its final decision in the case ... issued on December 23, the ITC ruled in favor of ... invalid. BMC President, James Xu called ... the ITC,s decision in this case. This victory for us ... beginning on the key patents in the case. ResMed chose ...
(Date:12/24/2014)... Wis. , Dec. 23, 2014 PuraMed ... marketer of over-the-counter (OTC) medicinal and healthcare products, announced ... of MigraPure® H, a hemp-based, advanced headache relief product, ... dispensaries in Colorado , ... . With the MigraPure H Advanced headache ...
(Date:12/24/2014)...   Synageva BioPharma Corp. (NASDAQ: ... products for rare disorders, today announced validation by ... Authorization Application (MAA) for sebelipase alfa for LAL ... for accelerated assessment, which has the potential to ... The MAA, and the Biologics License Application ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3
(Date:12/26/2014)... (PRWEB) December 26, 2014 The Biofeedback ... place March 24-28, 2015 in Rome, Italy and is ... includes workshops on a wide variety of ... well as peak performance training in athletes. The scientific ... the world. , Biofeedback monitoring allows clients to see ...
(Date:12/26/2014)... December 26, 2014 DW-InductionHeating.com (DaWei Induction ... designing, researching and developing, producing and marketing of a ... the business announces their new series of induction ... of the company, induction brazing refers to ... special filler material and heat. The manager says that ...
(Date:12/25/2014)... Dallas, TX (PRWEB) December 26, 2014 ... and Market Analysis to 2023” focuses on the ... commercial opportunities in the colorectal cancer market. Stivarga ... treatment of colon or rectal cancer. Boehringer Ingelheim ... inhibitor, for the treatment of refractory CRC in ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company ... collection of discounted prom dresses, most of which are ... of the company, the promotion is valid until Jan. ... expand the UK market. , The prom dresses in ... and styles: A-line strapless, empire strapless chiffon, one shoulder, ...
(Date:12/25/2014)... 2014 When head lice hits a home ... frenzy to get rid of it while keeping it from ... Gables now have the solution right in their neighborhood: ... Lice Troopers provides full spectrum head lice screening and treatment ... including Sunset, Key Biscayne, Brickell, Coconut Grove, Kendall, Pinecrest and ...
Breaking Medicine News(10 mins):Health News:Final Workshop Line-up Announced for 18th Annual Biofeedback Conference in Rome, Italy 2Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Coral Gables Florida Gets Ready to Be Lice-Free with Lice Troopers 2
... Cipla has offered to manufacture an antiviral drug for ... by Glaxo Smithkline. It has already made Tamiflu in its ... well known and popular as Tamiflu has but is cheaper ... Hameid, CEO of Cipla in a press release said:‘‘Zanamivir is ...
... as the first most common cause for death in ... stress echocardiography that can help predict life-threatening heart problems ... conducted among a group of diabetic women aged between ... type of stress test for suspected coronary disease that ...
... form chronic back pain, an increasing attention is being ... study has established that chiropractic care produces significantly // ... underwent the therapy had higher pain relief and satisfaction ... medical care. , ,The study has been conducted ...
... detected by using a hand-held scope called VELscope, which has ... by National Institute of Dental Craniofacial Research. The devise emits ... white light in detection of cancerous lesions in the mouth. ... oral cancer as better treatment is achieved when oral cancer ...
... National Laboratory are studying the biopolymer structural dynamics of ... new theory on protein folding unfolds the mystery of ... to diseases and the study is to be published ... Sciences. , ,The researchers used a technique called ...
... Britain can look forward to some relief, as a cannabis-based ... time, following approval from the Home Office for its importation ... be able to obtain an unlicensed, cannabis-based medicine on prescription ... it is yet to be licensed in the UK. The ...
Cached Medicine News:Health News:Cipla In India Can Manufacture Drug For Bird Flu 2Health News:Cipla In India Can Manufacture Drug For Bird Flu 3Health News:A Simple Test To Detect Heart Disease In Women Can Be Lifesaving 2Health News:Back Pain Can Now Be Cost-Effectively Treated By Chiropractic Care 2Health News:Relief For British MS Patients: Cannabis-Based Oral Spray 2
Bard Coude-Tip Latex Urethral Catheter, Two Eyes (Tiemann Model)...
Red Latex Bardex I.C. Foley 2-Way Catheter (Council Model)...
The BARDEX I.C. Catheter represents Bard's newest technology in providing protection against NUTI....
Used for injection into urethral strictures, bladder neck contracture, and the bladder wall. Supplied sterile in peel-open packages. Intended for one-time use....
Medicine Products: