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

BSO 1980-09-09

CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG

Applicant Portex, Inc.

K-Number K802065

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BYG 1980-09-09

PEEP FACE MASK

Applicant Vital Signs, Inc.

K-Number K801883

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DRS 1980-09-09

DISP. TRANSDUCER DOMES TD200 & TD300

Applicant Bio-Med Corp.

K-Number K802069

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GGW 1980-09-09

HEP-TROL

Applicant Helena Laboratories

K-Number K801932

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HGP 1980-09-09

FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM

Applicant Life Support, Inc.

K-Number K801984

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N/A 1980-09-06

PA-1 LOW PRESSURE ALARM

Applicant Puritan Bennett Corp.

K-Number K802112

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JLW 1980-08-27

TSH RIASSAY

Applicant Ria Diagnostics

K-Number K801691

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KWM 1980-08-27

TALEISNIK TOTAL WRIST PROSTHESIS

Applicant Dow Corning Wright

K-Number K800602

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FPA 1980-08-27

PRIMARY SOLUTION ADMIN. SET-#86-01-0 260

Applicant Y

K-Number K801871

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FPA 1980-08-27

MODEL 86-01-1 260 SOLUTION ADMIN. SET

Applicant Y

K-Number K801872

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FPA 1980-08-27

MODEL 86-21-0 260 SECONDARY MEDICATION

Applicant Y

K-Number K801873

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FRN 1980-08-27

SYRINGE INFUSION PUMP #2716

Applicant Harvard Apparatus, Inc.

K-Number K801904

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