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

GTQ 1980-04-24

RAPI/TEX ASO STANDARD SERUM

Applicant Calbiochem-Behring Corp.

K-Number K800642

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DXY 1980-04-24

MODEL 253-11 CYBERLITH PULSE GENERATOR

Applicant Intermedics, Inc.

K-Number K800895

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LCS 1980-04-24

DIGOCTK 125

Applicant Sorin Biomedica, Fiat, USA, Inc.

K-Number K800773

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DXQ 1980-04-24

MOD. MCI 17 MANUAL CUFF INFLATOR

Applicant Medasonics, Inc.

K-Number K800767

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JJY 1980-04-24

DIAGNOSTIC PRODUCTS CORP. RIA CONTROL

Applicant Diagnostic Products Corp.

K-Number K800813

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ESD 1980-04-24

RIONET &/OR RION HEARING AID MOD. HB-67S

Applicant Rion Acoustic Instruments, Inc.

K-Number K800738

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DBM 1980-04-24

AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY

Applicant Calbiochem-Behring Corp.

K-Number K800821

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DQK 1980-04-24

ECHO-COMP

Applicant Digisonics, Inc.

K-Number K800766

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DBE 1980-04-24

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY

Applicant Calbiochem-Behring Corp.

K-Number K800820

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CGR 1980-04-24

GAMMA STICK CORTISOL RIA KIT/STICK KIT

Applicant Alpha Gamma Laboratory

K-Number K800538

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JSJ 1980-04-24

CORN MEAL AGAR MEDIA

Applicant Isle Media and Sterile Products, Inc.

K-Number K800807

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KSS 1980-04-24

PRE-DENT SYSTEM

Applicant Pre-Dent System

K-Number K800736

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