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

JER 1979-10-26

DEN-MAT 4-MINUTE DENTURE CLEANER

Applicant Den-Mat Corp.

K-Number K791925

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FMQ 1979-10-26

SKIL-CARE SUPER-SOFT LIMB RESTRAINTS

Applicant Skil-Care Corp.

K-Number K792012

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EXB 1979-10-26

HOLLISTER STOMA POUCH SKIN BARRIER

Applicant Hollister, Inc.

K-Number K791526

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ELC 1979-10-26

MASTERSCALE II

Applicant Litton Dental Products

K-Number K791704

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DXY 1979-10-26

CARDIAC PACEMAKER C4000, C1000 SER.

Applicant Vitatron Medical BV

K-Number K791921

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EQJ 1979-10-26

OTOTOME BUR

Applicant American Sterilizer Co.

K-Number K792028

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FNM 1979-10-26

COMFICARE PAD (FOR SINGEL PT USE)

Applicant Hamilton Industries, Inc.

K-Number K792001

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FIE 1979-10-26

VITAL CATHETER

Applicant Hospal Medical Corp.

K-Number K791489

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ESD 1979-10-26

RIONET HEARING AID HB-64S

Applicant Rion Acoustic Instruments, Inc.

K-Number K791879

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DWS 1979-10-26

AORTIC OCCLUDER #000390

Applicant Edward Weck, Inc.

K-Number K792088

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DSF 1979-10-26

CRITIKON DUAL CHANNEL RECORDER

Applicant Critikon Company, LLC

K-Number K792105

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CFE 1979-10-26

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS

Applicant Hoffmann-La Roche, Inc.

K-Number K791373

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