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

ELC 1981-12-14

HYGIENTIST; CYCLOSON I & II; RETROFIT

Applicant Fibra Sonics, Inc.

K-Number K812909

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HGM 1981-12-10

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR

Applicant Epcom Medical Systems, Inc.

K-Number K813007

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DTB 1981-12-10

POLY-FLEX PACING LEADS

Applicant Intermedics, Inc.

K-Number K813028

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IFP 1981-12-10

10% NEUTRAL BUFFERED FORMALIN CONCENT

Applicant Surgipath

K-Number K812940

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JJE 1981-12-10

BECKMAN SYSTEM E4A

Applicant Beckman Instruments, Inc.

K-Number K813160

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KHE 1981-12-10

UROPAPER EIKEG

Applicant Syn-Kit, Inc.

K-Number K811815

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DTB 1981-12-10

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP

Applicant Telectronics, Inc.

K-Number K813134

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GWX 1981-12-10

CONPHAR, TUNING FORKS

Applicant Conphar, Inc.

K-Number K813304

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DXY 1981-12-10

SIEMENS-ELEMA PULSE GENERATOR 668 B

Applicant Siemens Corp.

K-Number K812610

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DTJ 1981-12-10

IONESCU-SHILEY VALVE HOLDER & HANDLE

Applicant Shiley, Inc.

K-Number K813276

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DXY 1981-12-10

BIPOLAR OPTIMA MP #255

Applicant Telectronics, Inc.

K-Number K813079

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LDF 1981-12-10

ETHICON* TEMP. CARDIAC PACING WIRE

Applicant ETHICON, Inc.

K-Number K813138

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