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

JWH 1982-02-10

101 TOTAL CONDYLAR KNEE SYSTEM

Applicant Intermedics Orthopedics

K-Number K813598

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KSK 1982-02-10

FREEZE DRIED FICIN

Applicant Biological Corp. of America

K-Number K813404

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KNX 1982-02-10

HOLLISTER FEMALE URINARY COLLECT SYS

Applicant Hollister, Inc.

K-Number K820234

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GZJ 1982-02-10

10D (TENS DEVICE)

Applicant Staodynamics, Inc.

K-Number K813283

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DFH 1982-02-10

DAKO PAP KIT K504

Applicant Dako Corp.

K-Number K812485

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DEW 1982-02-10

DAKO PAP KIT K505

Applicant Dako Corp.

K-Number K812484

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FNJ 1982-02-10

DEVICE FOR REPOSITIONING A BET PATIENT

Applicant Ali-Oop Co., Inc.

K-Number K813356

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KGO 1982-02-10

STERILE DISPOSABLE SURGICAL GLOVES

Applicant Intermarket Latex, Inc.

K-Number K812421

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FED 1982-02-10

KEY MED FOREIGN BODY REMOVAL TUBE

Applicant Keymed, Inc.

K-Number K813325

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FRN 1982-02-10

OPEN LOOP INFUSION PUMP

Applicant Iatric Devices

K-Number K820219

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N/A 1982-02-08

GLAUKON

Applicant Sonometrics Systems, Inc.

K-Number K812015

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LET 1982-02-05

PHENOBARBITAL ASSAY

Applicant Syva Co.

K-Number K820188

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