Notification Center

Results: 616



#Item
501Technology / Medical equipment / Food law / Pharmaceuticals policy / Medical device / Medical technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health

Spinal Elements, Inc. Prenwrket Notification - Spinal Elements Cerciage Systen 510(k) Summary Cerciage SystemtJL

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-08-06 18:53:44
502Food and Drug Administration / Gloves / Medical technology / Food law / Protective gear / Medical device / Federal Food /  Drug /  and Cosmetic Act / Medical glove / Center for Devices and Radiological Health / Medicine / Health / Technology

ASSURGUARD SDN. BHD. (Company No[removed]H) FEB[removed]FDA 510(k), Premnarket Notification : 510(k) Summary of Safety and Effectiveness Information Date: 01 December 2012

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-03-08 15:19:08
503Health / Food law / Pharmaceutical industry / Pharmaceuticals policy / Medical equipment / Medical device / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Technology

K130588- Pagel1 of 2 Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k) APR[removed]

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-05-06 11:18:53
504Medical equipment / Food law / Pharmaceuticals policy / Premarket approval / Medical device / Infusion set / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Medicine / Medical technology / Food and Drug Administration

Preniarket Notification 5 10(k) Submission Section III .Section

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-10-09 13:30:03
505Vertebral column / Food law / Pharmaceuticals policy / Premarket approval / Medical device / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Spondylolisthesis / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration

WIl 032%1 Stryker Spine Trio Trauma Spinal System Traditional 510(k) Premarket Notification STRYKER SPINE

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2011-04-25 00:30:56
506Medical equipment / Medical ultrasound / Food law / Medical ultrasonography / Medical device / Ultrasound / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Medical physics

JAN 1 a 2012 GE H-ealthcare 5 10(k) Premarket Notification Submission 510(k) Summary In accordance with 21 CFR[removed]the following summary of information is provided: Date: December 21, 2011

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-02-27 00:32:18
507Food law / Medical device / Medical equipment / Medical technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Peek / Medicine / Health / Food and Drug Administration

Special 51 0(k).Premarket Notification KFx APPIANFx h PEEK Suture Anchors and KFx APPIANFxW PEEK Tissue Anchors 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JUN

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-07-06 14:44:51
508Prosthetics / Implants / Food law / Medical device / Center for Devices and Radiological Health / Dental implant / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Title 21 of the Code of Federal Regulations / Medicine / Medical technology / Food and Drug Administration

KIP[removed]Special 510(k) Premarket Notification BioHorizons Tapered Internal Plus Implants

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-10-09 13:29:26
509Health / Medical equipment / Food law / Sensors / Medical device / Medical technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Technology / Food and Drug Administration

Inovise Medical, Inc. Sensors 13of[removed]k) Notification, Modification to AUDICOR

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2011-03-07 11:37:20
510Food and Drug Administration / Medical technology / Food law / Gloves / Pharmacology / Medical device / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Health / Technology

Abbreviated 510(k) Premarket Notification UTB3 Powder Free Nitrile Patient Exam Gloves 510(k) Summary Page1

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-08-06 18:52:44
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