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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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depuy contour unicompartmental knee prosthesis DEPUY ORTHOPAEDICS, INC. k000172 02/03/2000
depuy neuflex pip finger DEPUY, INC. k001922 08/29/2000
detach 18 and detach 11, neurological embolization coil system COOK, INC. k000651 11/24/2000
diamedix is-anti-dsdna test system DIAMEDIX CORP. k994424 02/18/2000
diamedix is-hsv 1&2 igm test system DIAMEDIX CORP. k002262 11/28/2000
diamedix is-rubella igm capture test system DIAMEDIX CORP. k001875 08/21/2000
diastat anti-cardiolipin igg/igm, model fcar 600 AXIS-SHIELD k001574 06/09/2000
dinamap pro 1000 monitor, model 1000 CRITIKON COMPANY,LLC k002248 09/21/2000
direct crown FLEXIBLE DIMENSIONS LLC. k001884 10/25/2000
disposable injector or disposable sclerotherapy needle ENTERIC MEDICAL TECHNOLOGIES k000646 04/13/2000

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