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

FZT 1979-09-12

SURGICAL INSTRUMENTS HEIFETZ DIGITATE

Applicant Edward Weck, Inc.

K-Number K791734

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EJR 1979-09-12

MIRADAPT* POLISHING INSTRUMENTS

Applicant Johnson & Johnson Professionals, Inc.

K-Number K791319

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DTB 1979-09-12

MODEL 484-01 BIPOLAR COAXIAL PACING LEAD

Applicant Intermedics, Inc.

K-Number K791377

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GWQ 1979-09-12

MODEL EEG-4217 ELECTROENCEPHALOGRAPH

Applicant Nihon Kohden America, Inc.

K-Number K791234

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DXN 1979-09-12

TENS-O-TEST

Applicant Curomatic, Inc.

K-Number K791637

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DFH 1979-09-12

ANTISERUM TO RABBIT IGG H & L CHAIN

Applicant Kent Laboratories, Inc.

K-Number K790706

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JCY 1979-09-12

JELCO & KVO CATHETER PLACEMENT UNIT

Applicant Jelco Laboratories

K-Number K791372

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GWQ 1979-09-12

ELECTROENCEPHALOGRAPHS MODELS 7209,7213

Applicant Nihon Kohden America, Inc.

K-Number K791150

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BSS 1979-09-12

FLEXIFLO ENTERAL PUMP SET

Applicant Abbott Laboratories

K-Number K791531

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EBF 1979-09-12

MIRADAPT* DENTAL RESTORATIVE

Applicant Johnson & Johnson Professionals, Inc.

K-Number K791318

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FMF 1979-09-12

PREPACELL-BONE MARROW SAMPLER

Applicant Applied Medical Devices, Inc.

K-Number K791660

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GDM 1979-09-12

BONE MARROW NEEDLE

Applicant Johannah Medical Services, Inc.

K-Number K791643

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