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Center for Devices and Radiological Health
Results: 3105

#	Item
611	Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants Add to Reading List Source URL: www.fda.gov Language: English Food law Pharmaceutical sciences Pharmaceuticals policy Pharmacology United States Public Health Service Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Guidance document Food and Drug Administration Medicine Health
612	Page 1/2 K140302 Exactech® Optetrak Logic® Porous Femoral Component Traditional 510(k[removed]k) Summary of Safety and Effectiveness Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-08-08 12:37:15 Orthopedic surgery Implants Medical equipment Food law Medical device Premarket approval Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Knee replacement Medicine Health Food and Drug Administration
613	1995 Broadway, 17th Floor New York, NY 10023–5882 tel +1–212–580–0800 fax +1–212–580–0898 www.softwarefreedom.org Add to Reading List Source URL: softwarefreedom.org Language: English - Date: 2014-05-01 15:03:58 Software licenses Food and Drug Administration Medical equipment Cardiac electrophysiology Neuroprosthetics Medical device Proprietary software Center for Devices and Radiological Health Artificial cardiac pacemaker Medicine Technology Health
614	JUN[removed]K1[removed]k) Summary (21 CER § [removed]c)) Submitter: Spirox, Inc. Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-07-18 16:16:07 Health Medical equipment Medical device Medical technology Food law Premarket approval Center for Devices and Radiological Health Synthes Title 21 of the Code of Federal Regulations Medicine Technology Food and Drug Administration
615	Contains Nonbinding Recommendations Contains Nonbinding Recommendations Contains Nonbinding Recommendations Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-10-30 08:39:14 Technology Premarket approval Center for Devices and Radiological Health Medical device Federal Food Drug and Cosmetic Act Validation Unity Program Memory Area International Space Station Food and Drug Administration Medicine Spaceflight
616	Kl331 10 Traditional 510(k) SubmissionPaeIo3 JUL[removed]Express LD Biliary Premounted Stent System Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-08-08 12:36:44 Interventional radiology Medical equipment Stent Bile duct Premarket approval Balloon catheter Medical device Center for Devices and Radiological Health Medicine Food and Drug Administration Implants
617	* 510(k) SUMMARY 1K140924 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-07-18 16:18:19 Health Federal Food Drug and Cosmetic Act Premarket approval Medical device Center for Devices and Radiological Health Design controls Dental restoration Title 21 of the Code of Federal Regulations Crown Medicine Dentistry Food and Drug Administration
618	K140358 JUN[removed]140358 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-07-18 16:17:34 Health Premarket approval Medical device Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Biomet Quality management system Medicine Food and Drug Administration Technology
619	K133568 Name: G-TUMV Vtoi Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-08-08 12:36:48 Food law Fertility medicine Pharmaceuticals policy Adulteration Federal Food Drug and Cosmetic Act Premarket approval Center for Devices and Radiological Health In vitro fertilisation Title 21 of the Code of Federal Regulations Medicine Food and Drug Administration Health
620	Traditional 510(k) Submission EqualizerTM Occlusion Balloon Catheter[removed]k) Summary Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-08-08 12:37:14 Food and Drug Administration Catheters Medical equipment Medical device Premarket approval Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Port Balloon catheter Medicine Medical technology Technology

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