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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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Applicant
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510(K)
Number
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Decision
Date
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datex-ohmeda s/5 device interfacing solution, n-disxxxx DATEX-OHMEDA k012531 11/02/2001
sepragel sinus GENZYME CORP. k012532 10/30/2001
modification to osi medical dolphin stand-alone pulse oximeter and accessories OSI MEDICAL, INC. k012533 08/22/2001
hi-torque middle support .012 guide wire with hydrocoat hydrophilic coating ADVANCED CARDIOVASCULAR SYSTEMS, INC. k012534 01/24/2002
drg disposable vaginal speculum DOCTOR'S RESEARCH GROUP, INC. k012535 03/01/2002
reprocessed powered arthroscopic accessories STERILMED, INC. k012536 11/02/2001
reprocessed imaging catheters STERILMED, INC. k012537 10/11/2002
tubing and connectors with trillium biopassive surface MEDTRONIC VASCULAR k012538 08/23/2001
verastep UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k012539 09/06/2001
bly-501 adaptor MICROMEDICAL INDUSTRIES, LTD. k012540 09/26/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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