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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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copeland resurfacing humeral heads BIOMET MANUFACTURING, INC. k010664 04/05/2001
transamerica digital ems TRANSAMERICA MEDICAL SYSTEMS k010665 04/27/2001
xps 3000 system with reciprocating adapter and suction cannulae MEDTRONIC XOMED, INC. k010666 05/07/2001
osteomark ntx point of care prescription home use OSTEX INTL., INC. k011052 07/30/2001
optima MEDICAL INDUSTRIES AMERICA, INC. k011053 04/20/2001
rads CHASON HEALTHCARE, LLC. k011054 07/30/2001
the o'neil sterile field urinary catheter kit with prep pads GO MEDICAL INDUSTRIES PTY. LTD. k011055 06/06/2001
arrow-trerotola percutaneous thrombolytic device or ptd ARROW INTL., INC. k011056 10/24/2001
intercept oral fluid drug test oral specimen collection device, model 503-xxxx ORASURE TECHNOLOGIES, INC. k011057 06/06/2001
telepress iii blood pressure monitor, model tpiii MERIDIAN MEDICAL TECHNOLOGIES LTD. k011058 10/23/2001

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