Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FHS 1980-02-13

GAMBRO LUNDIA COIL DIALYZER

Applicant Gambro, Inc.

K-Number K800174

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JSJ 1980-02-13

STAPHYLOCOCCUS MED. 110

Applicant Isle Media and Sterile Products, Inc.

K-Number K800156

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JXA 1980-02-13

CULTURIA MACCONKEY/CLED #DM87

Applicant Clinical Convenience Products, Inc.

K-Number K800215

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KSG 1980-02-13

BOVINE ALBUMIN 22% & 30% SOLUTIONS

Applicant Gotham Biologics, Inc.

K-Number K800189

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CIL 1980-02-13

CO2 CONTENT

Applicant American Monitor Corp.

K-Number K800111

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KWL 1980-02-11

UHR UNIVERSAL6HIP REPLACEMENT

Applicant Osteonics Corp.

K-Number K800207

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ESD 1980-02-11

SEARS BEHIND-THE-EAR HEARING AID

Applicant Int'L Hearing Aids, Inc.

K-Number K800113

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CJE 1980-02-11

CENTRIFICHEM ALP/ALKALINE PHOSPHATASE

Applicant Union Carbide Corp.

K-Number K800131

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DXY 1980-02-11

OVALITH P-BP BIPOLAR CARDIAC PACEMAKER

Applicant Coratomic, Inc.

K-Number K800194

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GXY 1980-02-11

TRU-PULSE PADS

Applicant Ipco Corp.

K-Number K800117

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HDW 1980-02-11

ONCE TM

Applicant G.D. Searle and Co.

K-Number K800162

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N/A 1980-02-11

TRANSDUCER

Applicant Kt Medical, Inc.

K-Number K800093

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