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

JTX 1978-09-14

STANDARDIZE TGCL & TGCH

Applicant American Monitor Corp.

K-Number K781376

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FJI 1978-09-14

DISSCAP

Applicant Hospal Medical Corp.

K-Number K781142

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JXA 1978-09-14

VAC-U-PAC KIDNEY CASSETTE

Applicant E-Z-Em, Inc.

K-Number K781536

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ESD 1978-09-14

HEARING AID, UNITRON MODEL 960PL

Applicant Unitron Industries, Inc.

K-Number K781513

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GWL 1978-09-14

PREAMPLIFIER MODEL 113

Applicant Princeton Applied Research Corp.

K-Number K781289

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IYE 1978-09-14

CLINAC 12/10

Applicant Varian Assoc., Inc.

K-Number K781174

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GKL 1978-09-14

HEMAC LASER HEMATOLOGY SYSTEM

Applicant Ortho Instruments

K-Number K781146

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KPQ 1978-09-14

XIMATRON IV

Applicant Siemens Elema AB

K-Number K781496

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N/A 1978-09-14

CAMERAS, MULTI-IMAGE

Applicant Dunn Instruments, Inc.

K-Number K781214

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GKR 1978-09-14

HEMOGLOBINOMETER MODEL 720 B

Applicant Innovative Medical Systems, Inc.

K-Number K781361

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KPQ 1978-09-14

EMI SIMULATOR REMOTE CONTROL CONSOLE

Applicant Emi Medical, Inc.

K-Number K781519

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KIE 1978-09-14

MODEL 5000, LIQUID CHROMATOGRAPHY

Applicant Varian Assoc., Inc.

K-Number K781379

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