Bd Autoshield Pen Needle

• • Terminated Z-0838-2007 FDA Unclassified (pre-2012) ·initiated 23 Apr 2007

  Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)

510(k) Number

K060007 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

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• Bd Pen Needle

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• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

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