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Found 4 results
510(k) Data Aggregation
K Number
K011325Device Name
MEDIFIX URETEROSCOPE
Manufacturer
MEDIFIX, INC.
Date Cleared
2001-07-25
(85 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDIFIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992474Device Name
ARTHROSCOPE / MEDIFIX INC.
Manufacturer
MEDIFIX, INC.
Date Cleared
1999-09-23
(59 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDIFIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Operative and Diagnostic Arthroscopy for visual imaging and light transmission to the operative area.
The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.
Device Description
Not Found
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K Number
K992480Device Name
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
Manufacturer
MEDIFIX, INC.
Date Cleared
1999-09-23
(59 days)
Product Code
HET, GCJ
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
MEDIFIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.
Device Description
Not Found
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K Number
K992483Device Name
MEDIFIX INC.
Manufacturer
MEDIFIX, INC.
Date Cleared
1999-08-30
(35 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDIFIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Operative and Diagnostic Cystoscopy for visual imaging and light transmission.
Device Description
Cystoscopes
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