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

HGC 1977-07-27

GUSBERG HYSTERECTOMY CLAMP

Applicant J. Sklar Mfg. Co., Inc.

K-Number K771344

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KDP 1977-07-27

INSTATEMP

Applicant H.I. Silverman, D.Sc.

K-Number K770944

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FMI 1977-07-26

TERUFUSION BLOOD ADMIN. SET

Applicant Terumo America, Inc.

K-Number K771209

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DRT 1977-07-25

SURGIPULSE HEART RATE MONITOR

Applicant Stryker Corp.

K-Number K771199

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ILC 1977-07-21

QUADRIPLEGIC MEAT KNIFE

Applicant Fred Sammons, Inc.

K-Number K771274

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N/A 1977-07-21

CPK-INT TEST

Applicant Hycel, Inc.

K-Number K771154

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N/A 1977-07-21

CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500

Applicant Varian Assoc., Inc.

K-Number K770827

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JQP 1977-07-21

DATA REDUCTION SYSTEM, DP-3000

Applicant Beckman Instruments, Inc.

K-Number K770877

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IQM 1977-07-21

FINGEO EXTENSION SPLINTS

Applicant Fred Sammons, Inc.

K-Number K771287

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JBQ 1977-07-21

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K-Number K770942

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GIG 1977-07-21

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET

Applicant The Dow Chemical Co.

K-Number K771101

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CIX 1977-07-21

UNIPAK ALBUMIN

Applicant Harleco

K-Number K771094

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