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

JDI 1983-01-17

HC 1M METALBACKED ACETABULAR CUP

Applicant Osteonics Corp.

K-Number K823419

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HQA 1983-01-17

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

Applicant Keller Instruments, Inc.

K-Number K823835

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N/A 1983-01-17

BARIUM ENEMAS

Applicant The Healthcare Group, Inc.

K-Number K828661

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BXB 1983-01-14

SUTTER CPM

Applicant Sutter Biomedical, Inc.

K-Number K823539

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GCY 1983-01-14

STRYKER CONSTAVAC

Applicant Stryker Corp.

K-Number K823284

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DRF 1983-01-14

SWITCHING UNIT ELECTRODE CATHETERS

Applicant Webster Laboratories, Inc.

K-Number K823361

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DTB 1983-01-14

LIFELINE -UNIPOLAR LEAD #487-05

Applicant Intermedics, Inc.

K-Number K823508

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KNO 1983-01-14

WHEELCHAIR PATIENT RESTRAINTS

Applicant Danek Medical, Inc.

K-Number K823816

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N/A 1983-01-14

ABC BRAND

Applicant Beiersdorf, Inc.

K-Number K823793

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KNN 1983-01-14

CHAIN KIT

Applicant Berkeley Electric Wheelchair Co.

K-Number K823875

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CJE 1983-01-14

ALKALINE PHOSPHATASE

Applicant Analytical & Research Chemicals, Inc.

K-Number K823786

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IBJ 1983-01-14

PATHOLOGY INSTRUMENTATION & ACCESSORIES

Applicant Iris Remote Imaging Systems

K-Number K823040

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