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

DXY 1980-08-27

VIVALITH 5, - MDL-201A & TDL-201A

Applicant Pacesetter Systems

K-Number K801763

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FOZ 1980-08-27

BURRON MICROCATH INTRA. CATH. PLACEMENTT

Applicant Burron Medical Products, Inc.

K-Number K801941

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CDZ 1980-08-27

TESTOSTERONE KIT

Applicant Immuchem Corp.

K-Number K801666

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KPE 1980-08-27

TOTAL PARENTERAL NUTRITION SET BAG

Applicant Cutter Laboratories, Inc.

K-Number K801652

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GNC 1980-08-27

SALMONELLA FLAGELLAR A ANTIGEN & B

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K801693

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FLL 1980-08-27

RTM SYSTEM (REMOTE TEMPERATURE MONITOR)

Applicant Remote Technologies, Inc.

K-Number K801423

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FMP 1980-08-27

FLOTATION PAD FOR OPERATING TABLE

Applicant Action Products, Inc.

K-Number K801694

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DXN 1980-08-27

BIOMEGA #423-B BLOOD PRESSURE & PULSE CK

Applicant Bio Mega Diagnostic, Inc.

K-Number K801923

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EGD 1980-08-27

HOWMEDICA BITE BLOCK

Applicant Howmedica Corp.

K-Number K801911

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FES 1980-08-27

MMI/GAELTEC CATHETER TIP PRESS. TRANSDU

Applicant Medical Measurements, Inc.

K-Number K801757

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DSH 1980-08-27

MODEL 9200 VIS-U-SCAN

Applicant Del Mar Avionics

K-Number K801832

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FIQ 1980-08-27

SSC8 SORENSON SUBCLAVIAN CATHETER

Applicant Sorensen Research

K-Number K801478

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