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

KIS 1978-01-20

GUINEA PIG WHOLE SERUM

Applicant Northeast Biomedical Labs., Inc.

K-Number K780009

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GNS 1978-01-20

GOAT ANTI-INFLUENZA ANTISERA

Applicant Northeast Biomedical Labs., Inc.

K-Number K780006

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GOK 1978-01-20

GOAT ANTI-RUBELLA ANTISERA

Applicant Northeast Biomedical Labs., Inc.

K-Number K780010

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ESD 1978-01-20

HEARING AID, BEHIND-THE-EAR

Applicant Maico Hearing Instruments, Inc.

K-Number K780067

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JDI 1978-01-20

PROSTHESIS, DOUBLE CUP

Applicant Depuy, Inc.

K-Number K780052

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GOK 1978-01-20

RUBENOSTICON

Applicant Organon, Inc.

K-Number K780063

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GNS 1978-01-20

GOAT ANTI-INFLUENZA ANTISERA

Applicant Northeast Biomedical Labs., Inc.

K-Number K780005

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DID 1978-01-20

AMINOGLYCOSIDE TEST SYSTEM

Applicant Nichols Institute Diagnostics

K-Number K780048

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FSM 1978-01-20

INSTRUMENT TRAY

Applicant Med Fusion Systems, Inc.

K-Number K772266

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JTY 1978-01-20

CULTURE MEDIA/ISOLA. PATHO. NEISSERIA

Applicant Diagnostic Culture System

K-Number K780022

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EAZ 1978-01-17

DENTAL LIGHT

Applicant Chemetron Dental Products

K-Number K772351

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CAF 1978-01-17

INSPIRON MANIFOLD (SINGLE)

Applicant C.R. Bard, Inc.

K-Number K772295

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