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

IPS 1977-04-05

UNICET I

Applicant Union Carbide Corp.

K-Number K770529

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EKP 1977-04-05

ENDODONTIC INSTRUMENTS, R&R CUTWELL

Applicant Ransom and Randolph

K-Number K770598

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CIT 1977-04-05

REAGENT GOT, ENZYME

Applicant Icn Pharmaceuticals, Inc.

K-Number K770318

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LCS 1977-04-05

PHALDEBAS DIGOXIN RIA

Applicant Pharmacia, Inc.

K-Number K770322

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JOL 1977-04-05

STERILE SUCTION CATHETER W/CONTROL

Applicant Chesire Laboratories

K-Number K770233

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DXE 1977-04-05

CATHETER, EMBOLECTOMY, UMI

Applicant Universal Medical Instrument Corp.

K-Number K770569

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DXY 1977-04-05

CENTURION

Applicant Johnson & Johnson Professionals, Inc.

K-Number K770419

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ILK 1977-03-30

PORT-A-BATH

Applicant Kathco, Inc.

K-Number K770294

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FPK 1977-03-30

LUER-LOCK EXTENSION SET

Applicant American Viggo

K-Number K770174

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GBX 1977-03-30

SUMP DRAIN, W/FILTER, ARGYLE EDLICH

Applicant Sherwood Medical Industries

K-Number K770442

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KNX 1977-03-30

MEMBRANE SOURCE-EX SERIES DIALYZER CART.

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K770516

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FPA 1977-03-30

ERIKA I.V. ADMINISTRATION SET

Applicant Erika, Inc.

K-Number K770171

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