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

ILH 1982-09-17

TOTAL FINGER FLEXION SPLINT

Applicant Alimed, Inc.

K-Number K822651

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KNT 1982-09-17

ROMBEAU GASTROSTOMY-JEJUNAL TUBE

Applicant Hedeco

K-Number K822380

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JIS 1982-09-17

CREATININE STANDARD #65072

Applicant Emd Chemicals, Inc.

K-Number K822477

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FXX 1982-09-17

MULTIPLE SURGICAL MASK

Applicant Surgilite Intl., Inc.

K-Number K822481

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JIS 1982-09-17

CALCIUM STANDARD, ITEM #65075

Applicant Emd Chemicals, Inc.

K-Number K822473

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KZD 1982-09-17

CREST PRESSURE INFUSOR

Applicant Crest Medical Equipment

K-Number K822434

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N/A 1982-09-15

ATC BIOELECTROGRAPHIC MONITOR MODEL I.

Applicant Advantage Medical Systems, Inc.

K-Number K822626

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N/A 1982-09-15

BI-4520 DUAL IMPEDOMETER

Applicant Farrall Instruments, Inc.

K-Number K821723

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JIT 1982-09-14

BILIRUBIN CALIBRATOR #65071

Applicant Emd Chemicals, Inc.

K-Number K822479

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ETF 1982-09-14

NAGASHIMA SN-SP UNIT AND CHAIR

Applicant Kelleher Corp.

K-Number K822016

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CEO 1982-09-14

PSI INORGANIC PHOSPHORUS

Applicant Pointe Scientific, Inc.,

K-Number K822470

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KMA 1982-09-14

POWDER BLOWERS

Applicant Kelleher Corp.

K-Number K822351

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