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

IYO 1983-08-16

US-1000 ULTRASONIC IMAGING SYSTEM

Applicant Nidek, Inc.

K-Number K832331

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CDM 1983-08-16

FITKIT I CHECKUP KIT

Applicant Patton, Boggs & Blow

K-Number K821799

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FRN 1983-08-16

CORPAK VTR 300 ENTERNAL PUMP

Applicant Corpak Co.

K-Number K832167

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DXY 1983-08-16

IMPLANTABLE PROGRAM. CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K-Number K831771

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CHH 1983-08-16

CHOLESTEROL HIGH PERFORMANCE-K

Applicant Boehringer Mannheim Corp.

K-Number K832158

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KZR 1983-08-16

CHROM-PREP

Applicant Hamilton Co.

K-Number K832201

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HPT 1983-08-16

DIGILAB 350 THE KRAKAU PERIMETER

Applicant Bio-Rad

K-Number K832175

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GWE 1983-08-16

EVOKED 3500 POTENTIAL SYSTEM

Applicant Tracor Northern, Inc.

K-Number K832084

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MBV 1983-08-16

MARK I TOTAL KNEE SYS. ARTHROPLASTY

Applicant Advanced Biosearch Assn.

K-Number K832302

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HRY 1983-08-16

P.C.A. UNICOMPARTMENTAL KNEE PROSTHES

Applicant Howmedica Corp.

K-Number K831143

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HQJ 1983-08-16

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK

Applicant Bcd Products, Inc.

K-Number K831773

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JHJ 1983-08-16

GAMMA SLIDE TEST FOR PREGNANCY

Applicant Gamma Biologicals, Inc.

K-Number K832473

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