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

HEX 1982-06-16

CERVISCOPE OPTICAL SYSTEM

Applicant Fotomedics, Inc.

K-Number K821616

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DRS 1982-06-16

VIRAGARD/VIRASHIELD

Applicant Tri-Med, Inc.

K-Number K820459

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FOX 1982-06-16

MAGUN BASE I.V. POLE

Applicant Manuco Manufacturing Co., Inc.

K-Number K821405

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GAX 1982-06-16

LATEX PENROSE DRAIN TUBING

Applicant Abco Dealers, Inc.

K-Number K821700

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N/A 1982-06-16

THERMA-SCAN

Applicant T. G. & E. Medical

K-Number K820941

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KRH 1982-06-16

PUIG MASSANA-SHILEY ANNULOPLASTY RING

Applicant Shiley, Inc.

K-Number K821261

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GZJ 1982-06-16

OMNI TENS

Applicant Omni Intl., Inc.

K-Number K821523

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CKA 1982-06-14

DOWFLOW ALT-UV DETERMINATION

Applicant The Dow Chemical Co.

K-Number K821536

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LFG 1982-06-14

DOXEPIN TRI-CY TEST SET

Applicant Wien Laboratories, Inc.

K-Number K821652

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EJS 1982-06-14

DUALLOR 'R'

Applicant J. Aderer, Inc.

K-Number K821572

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HLH 1982-06-14

TRIAL LENS SET

Applicant Medical Equipment Designs, Inc.

K-Number K821082

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EKN 1982-06-14

ENDODONTIC PAPERPOINTS

Applicant Roeko

K-Number K821625

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