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

FPA 1980-08-12

MCGRAW I.V. ADMINISTRATION SET

Applicant American Hospital Supply Corp.

K-Number K801540

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FPB 1980-08-12

BIMECO FILTERED EXTENSION SET

Applicant Burron Medical Products, Inc.

K-Number K801605

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KDJ 1980-08-12

CLIRANS TE15 HOLLOW FIBER DIALYZER

Applicant Terumo America, Inc.

K-Number K801193

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FON 1980-08-12

HOLLISTER DRAINAGE POUCH

Applicant Hollister, Inc.

K-Number K801504

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EMA 1980-08-12

SILICAP

Applicant Vivadent (Usa), Inc.

K-Number K801227

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KDJ 1980-08-12

PERITONEAL DIALYSIS CYCLER SET W/PUMP

Applicant American Medical Products, Inc.

K-Number K801220

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HND 1980-08-12

MCCULLEY CONTINUOUS SUTURE TIGHTNER

Applicant Edward Weck, Inc.

K-Number K801608

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KNX 1980-08-12

COVER-ALL MALE INCONTINENCE DEVICE

Applicant The Urology Group

K-Number K801629

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FJI 1980-08-12

CLIRANS TE10 HOLLOW FIBER DIALYZER

Applicant Terumo America, Inc.

K-Number K801192

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FPA 1980-08-12

MODEL 72-81-0 UNVENTED SOLUTION ADM. SET

Applicant Y

K-Number K801613

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HFC 1980-08-12

ACCU-PAP T ZONE SAMPLER

Applicant Robert Hasselbrack, M.D.

K-Number K801238

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FRN 1980-08-12

ABBOTT/SHAW LIFE CARE PUMP MODEL 3

Applicant Abbott Laboratories

K-Number K801441

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