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

EMA 1981-09-25

CAVITRON

Applicant G-C Intl. Corp.

K-Number K812568

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BZG 1981-09-25

SPIROMETER 210/211

Applicant Medix Medical Electronics (U.S.A.), Inc.

K-Number K812039

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ILH 1981-09-25

VELCRO FINGER/TOE SPLINT

Applicant Maddak, Inc.

K-Number K812654

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DYG 1981-09-25

SWAN-GANZ & EDSLAB HEPARIN COATED CATH.

Applicant American Edwards Laboratories

K-Number K812563

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EBF 1981-09-25

BEAUFILL

Applicant Sci-Pharm, Inc.

K-Number K812545

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LBH 1981-09-25

COBEAU

Applicant Sci-Pharm, Inc.

K-Number K812548

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LDD 1981-09-25

2000 SERIES PORTABLE RESUSCITATION SYST.

Applicant Life Science Instrumentation, Inc.

K-Number K812519

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DQK 1981-09-25

KONTRON PMS 7000

Applicant Kontron Instruments, Inc.

K-Number K812354

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CAP 1981-09-25

VENTI-MONITOR MODEL 101

Applicant Medix Medical Electronics (U.S.A.), Inc.

K-Number K812041

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EBF 1981-09-25

ADAPTIC* C.F.S.

Applicant Johnson & Johnson Professionals, Inc.

K-Number K812449

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BYH 1981-09-25

SHERWOOD WATER TRAP

Applicant Sherwood Medical Co.

K-Number K812569

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DRT 1981-09-25

CARDIORATER CR-5

Applicant Life Science Instrumentation, Inc.

K-Number K812146

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