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

JHJ 1983-06-22

B HCG-CHECK

Applicant Diagnostic Technology, Inc.

K-Number K831468

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GQL 1983-06-22

MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION

Applicant Syva Co.

K-Number K830953

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CJE 1983-06-22

PARAMAX ALKALINE PHOSPHATASE REAGENT-

Applicant American Dade

K-Number K831480

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DPS 1983-06-22

UNIVERSAL MEDDARS SYSTEM

Applicant Electronics For Medicine, Inc.

K-Number K830791

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MBV 1983-06-22

MARK I & II TOTAL KNEE REPLACE. SYS

Applicant Advanced Biosearch Assn.

K-Number K830726

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KIT 1983-06-22

RPMI-1640 MEDIUM W/L-GLUTAMINE &

Applicant Sigma Chemical Co.

K-Number K831519

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JHJ 1983-06-22

EVENT-TEST SLIDE

Applicant Icl Scientific

K-Number K831383

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FMT 1983-06-22

RESUSCITAIRE

Applicant Vickers America Medical Corp.

K-Number K830748

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N/A 1983-06-20

MORWEL CANNULA

Applicant Morwel Corp.

K-Number K831520

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NAD 1983-06-20

UNI-THANE

Applicant Carapac Systems, Inc.

K-Number K831611

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IPF 1983-06-20

MEASURE-UP MUSCLE STIMULATOR

Applicant Measure-Up Intl., Inc.

K-Number K831003

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FQM 1983-06-20

ORTHO WRAP

Applicant Fast Wrap Co., Inc.

K-Number K830622

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