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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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inion cps 2.0 orthognathic plate INION LTD. k013039 10/05/2001
discovery elbow BIOMET ORTHOPEDICS, INC. k013042 10/10/2001
candela clearbeam pulsed dye laser CANDELA CORP. k013043 10/11/2001
biocuff,c, models 236018, 236028, 236036 BIONX IMPLANTS, INC. k013057 10/12/2001
fas endoluminal brush FAS MEDICAL LTD. k012641 10/15/2001
raichem bun rate reagent HEMAGEN DIAGNOSTICS, INC. k012649 10/15/2001
reprocessed unipolar laparoscopic/endoscopic instruments ALLIANCE MEDICAL CORP. k012625 10/22/2001
stony brook surgical innovaions sterna-wire (sternal sutures) STONY BROOK SURGICAL INNOVATIONS, INC. k013059 10/22/2001
gynecare tension-free vaginal tape system GYNECARE CENTER k012628 10/26/2001
tourniquet cuff; pneumatic tourniquet MEDICAL INSTRUMENTS TECHNOLOGY, INC. k012632 10/26/2001

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