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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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3.5 mm laparoscope (lg100, lg103) SURGICAL IMAGE LABORATORIES, INC. k001594 06/12/2000
surgi-vision urethral coil SURGI-VISION, INC. k002345 10/11/2000
edta root canal cleanser SUPER GLIDE, INC. k003422 01/19/2001
natural-knee ii system-durasul tibial insert and durasul all-poly patella SULZER ORTHOPEDICS, INC. k002335 10/25/2000
modified to modular fr severe bone loss trauma SULZER MEDICA k002324 08/24/2000
spline dental implant system SULZER CALCITEK, INC. k010073 01/19/2001
newgen system STRYKER INSTRUMENTS k002619 11/16/2000
surgical simplex p radiopaque bone cement and acm and mixevacii STRYKER CORP. k002652 01/26/2001
stryker heated insufflator tube set STRYKER CORP. k003792 02/21/2001
stockert a242 and a252 series arterial femoral cannulae STOECKERT INSTRUMENTE k001961 01/25/2001

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