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

KSE 1980-04-16

MONITEMP BLOOD PACK TEMP. MONITOR

Applicant Liquid Crystal Products, Inc.

K-Number K800667

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DRQ 1980-04-16

SURGERY DISPLAY SYSTEM

Applicant Kent Barker & Assoc.

K-Number K800488

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ETD 1980-04-16

GOODE T-TUBE, BIOLITE COATED SILICONE/TU

Applicant Xomed, Inc.

K-Number K800727

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FRC 1980-04-16

STEAROTHERMOHILUS SPORE STRIPS

Applicant Mdt Corp., Inc.

K-Number K800482

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HIR 1980-04-16

PERITONE

Applicant Laurie Ann Kaiser, Ph.D.

K-Number K800191

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N/A 1980-04-16

SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS

Applicant Diagnostic Solutions, Inc.

K-Number K800671

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FPA 1980-04-16

B-D STASET, I.V. FLOW CONTROLLER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K800600

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KLB 1980-04-16

TOBRAMYCIN RIA KIT

Applicant Antibodies, Inc.

K-Number K800743

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GCY 1980-04-16

SURGIVAC TM

Applicant Snyder Laboratories, Inc.

K-Number K800578

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DRS 1980-04-16

MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO

Applicant Graphic Controls Corp.

K-Number K800705

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CKE 1980-04-16

STANBIO PROSTATIC ACID PHOSPHATASE TEST

Applicant Stanbio Laboratory

K-Number K800693

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LAS 1980-04-16

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II

Applicant Ortho Diagnostics, Inc.

K-Number K800357

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