Special K

Results: 1345



#Item
991Food law / Pharmaceuticals policy / Interventional radiology / Medical device / Medical equipment / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Coil / Embolization / Medicine / Health / Food and Drug Administration

Special 510(k) TWrkeiJon MlicroPlex Embolic System (MCS) Line Extension

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-11-14 08:33:22
992Medical equipment / Food law / Pharmaceuticals policy / Medical device / Medical technology / Center for Devices and Radiological Health / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Title 21 of the Code of Federal Regulations / Medicine / Food and Drug Administration / Health

Page 1 of 2 B. Special 510(k) Summary (as required by 21 CFR[removed]Sovereigns mini System

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-02-06 08:16:35
993Food and Drug Administration / Plastic surgery / Food law / Medical technology / Syringe / Medical device / Fat transfer / Liposuction / Title 21 of the Code of Federal Regulations / Medicine / Health / Medical equipment

Medi-Klian (USA) Inc. Lipokit with disposable 50cc AFT Syringe Special 510(k) Notification DEC

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-01-09 11:27:08
994Telehealth / Food and Drug Administration / Medical informatics / DICOM / Hologic / Picture archiving and communication system / Mammography / Medical device / Federal Food /  Drug /  and Cosmetic Act / Medicine / Health / Medical imaging

Special 510(k) K103385 Securiew DX Hologic, Inc. FEB

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2011-03-07 11:37:17
995Medical terms / Invasiveness of surgical procedures / Medical device / Surgical instrument / Medicine / Surgery / Medical equipment

Page 1 of 4 SPECIAL 510(k): K132431 DEVICE MODIFICATION Solta Medical, Inc. 510(k) SUMMARY Thermage CPT® System (TG-28)

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-10-09 09:33:01
996Anatomy / Diabetes / Hematology / Blood tests / Equilibrium chemistry / Glycated hemoglobin / Medical device / Food and Drug Administration / Diabetes management / Medicine / Biology / Hemoglobins

SEP Infopia Co.,Ltd. Glycosylated Hemoglobin (ilbAic) Monitoring System Special 510(k) for In Vitro Diagnostic Device IV.

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2012-10-09 13:29:17
997Health / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medical device / Design controls / Center for Devices and Radiological Health / Endoscopy / Telescopic sight / Proctoscopy / Medicine / Food and Drug Administration / Technology

THD S.p.A. SPECIAL 510O(K) NOTIFICATION iNOCOP034

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2011-04-25 00:31:27
998

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2011-03-07 11:37:45
    999Health / Food law / Medical equipment / Pharmaceuticals policy / Pharmaceutical industry / Medical device / Premarket approval / Title 21 of the Code of Federal Regulations / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Technology

    Page 7-2 SunTech Medical, Inc. Special 510(k) Submission Tango M2 510(k) Summary

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    Source URL: www.accessdata.fda.gov

    Language: English - Date: 2012-12-06 10:13:32
    1000Medical device / Premarket approval / Peritoneal dialysis / Federal Food /  Drug /  and Cosmetic Act / Ascites / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Design controls / Catheter / Medicine / Food and Drug Administration / Health

    Bard Access Systems, Inc. Aspirat Peritoneal Drainage System Special 510(k) Premarket Notification -Pae

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    Source URL: www.accessdata.fda.gov

    Language: English - Date: 2011-06-27 00:48:59
    UPDATE