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

INO 1980-11-19

CONVALESCENT RECLINER

Applicant Winfield Co., Inc.

K-Number K802803

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LFL 1980-11-18

CAVITRON ULTRASONIC SURG. ASPIR. CUSA

Applicant Cavitron Corp.

K-Number K801623

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CBK 1980-11-18

IC-2 VENTILATOR

Applicant Bio-Med Devices, Inc.

K-Number K801890

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KDC 1980-11-17

SHARPS CADDY MAGNETIC & SHARPS CADDY FOA

Applicant Instranetics, Inc.

K-Number K802866

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DYN 1980-11-14

SILENTSLEEP

Applicant Slumber Research, Inc.

K-Number K801927

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FSM 1980-11-14

A.M.P.C.O. SKIN SCRUB TRAY

Applicant Associated Medical Products Co.

K-Number K802570

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N/A 1980-11-13

WORRELL PATELLA FEMORAL SHIELD

Applicant Depuy, Inc.

K-Number K801934

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DTB 1980-11-13

MEDTRONIC MODEL 6958

Applicant Medtronic Vascular

K-Number K800870

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KHO 1980-11-12

CYBREX TM FPQ FLUORESCENE POLARIZATION

Applicant Abbott Laboratories

K-Number K802579

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FPX 1980-11-12

CENTRAL VENOUS CATHETER DRESSING TRAY

Applicant American Medical Disposable, Inc.

K-Number K802384

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HEB 1980-11-12

KOTEX SECURITY TUBE TAMPONS

Applicant Kimberly-Clark Corp.

K-Number K802193

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FKR 1980-11-12

BICARB-O-MATE HEMODIALYSIS SOD. BICARB.

Applicant Renal Systems, Inc.

K-Number K802465

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