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

N/A 1980-07-21

CYBREX PHENOBARBITAL

Applicant Abbott Laboratories

K-Number K801566

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LEJ 1980-07-21

TAN YEAR ROUND SUN BED

Applicant Tan-Year Round, Inc.

K-Number K801341

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DZE 1980-07-21

ZEST PLANT

Applicant Zest Anchors, Inc.

K-Number K801524

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BSY 1980-07-21

ARGYLE SAF-T-MARK SUCTION CATHETER

Applicant Sherwood Medical Co.

K-Number K801551

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DXK 1980-07-21

LINEAR ARRAY SCANNER

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K800805

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JAA 1980-07-21

SFX-90 TABLE/SPOTFILMER W/FLUORICON L200

Applicant General Electric Co.

K-Number K801320

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FJI 1980-07-21

GF-120-L DIALYZER

Applicant Gambro, Inc.

K-Number K801370

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IOR 1980-07-21

ROLLS ROLLITE WHEELCHAIR

Applicant Invacare Corp.

K-Number K801557

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LEJ 1980-07-21

SUNBURST, SUN SYSTEMS OR BC2

Applicant Sun Ray Mfg., Inc.

K-Number K801163

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ILI 1980-07-21

ARM SLING

Applicant The Owenby Co.

K-Number K801531

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HHK 1980-07-21

SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES

Applicant Sherwood Medical Industries

K-Number K801070

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FKT 1980-07-21

K1 POTASSIUM ACETATE ADDITIVE

Applicant Organon Teknika Corp.

K-Number K801385

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