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

DRT 1980-09-26

HS10 PORTABLE OPERATING ROOM MONITOR

Applicant Medtel Pty. , Ltd.

K-Number K802184

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DTB 1980-09-26

MEDTRONIC MODEL 69575

Applicant Medtronic Vascular

K-Number K800944

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CBN 1980-09-26

CLEAN-AIR POLLUTION REDUCTION SYSTEM

Applicant Porter Instrument Co., Inc.

K-Number K802067

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KKX 1980-09-26

BOUNDARY SINGLE-USE DRAPE

Applicant Procter & Gamble Mfg. Co.

K-Number K802148

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JJQ 1980-09-26

MICRO-FLOW SPECTROPHOTOMETER CL-720

Applicant Shimadzu Precision Instruments, Inc.

K-Number K801957

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FJI 1980-09-26

RENAFLO HOLLOW FIBER DIALYZER #100.1

Applicant Renal Systems, Inc.

K-Number K801827

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JHX 1980-09-26

EMBRIA-CK

Applicant Intl. Immunoassay Laboratories, Inc.

K-Number K801728

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ESD 1980-09-26

RIONET HEARING AID HB-69C

Applicant Rion Acoustic Instruments, Inc.

K-Number K802053

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GBA 1980-09-26

BALLOON RETENTION CHEST CATHETER

Applicant Loseff Medical Designers, Ltd.

K-Number K802025

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JFL 1980-09-26

BAKER DIAG. ULTRARATE CO2 REAGENT KIT

Applicant J.T. Baker Chemical Co.

K-Number K802035

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GAB 1980-09-26

SCANLAN STERNUM NEEDLE-SUTURE

Applicant Scanlan Intl., Inc.

K-Number K801976

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BTI 1980-09-26

AIR COMPRESSOR ADAPTOR KIT

Applicant Hudson Oxygen Therapy Sales Co.

K-Number K802253

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