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U.S. Department of Health and Human Services

Medical Device Recalls

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Date Classified to: 03/12/2014 510(K) Number: K070359
 
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Product Description
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OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01,... 2 Aug-27-2015 Nidek Inc
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. 2 Aug-27-2015 MRP, LLC dba AMUSA
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software ... 2 Aug-27-2015 GE Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Vi... 2 Aug-27-2015 GE Healthcare
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary ... 2 Aug-27-2015 Synthes (USA) Products LLC
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stabili... 2 Aug-27-2015 Stryker Sustainability Solutions
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for u... 2 Aug-27-2015 Baxter Healthcare Corp.
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. i... 2 Aug-27-2015 Baxter Healthcare Corp.
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking... 2 Aug-27-2015 Baxter Healthcare Corp.
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with ... 2 Aug-27-2015 Baxter Healthcare Corp.

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