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OLYMPUS LACTATE, OSR6193

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

FDA 510(k)
FDA Class 2 ·Immunology

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

FDA 510(k)
FDA Class 2 ·Hematology

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS

FDA 510(k)
FDA Class 2 ·Physical Medicine

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.

FDA 510(k)
FDA Class 2 ·Immunology

OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION

Eakin Cohesive Paste

FDA registration
T.G. EAKIN, LTD.·1 product·🇬🇧 United Kingdom

EAKIN FISTULA AND WOUND POUCHES

FDA registration
T.G. EAKIN, LTD.·1 product·🇬🇧 United Kingdom

SET Chiropro+ 3rd Gen CA 1:2.5L

Device
EU MDR · Eu Md Class 2a ·Bien-Air Dental SA·On the market·31 countries

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

Cervical Orthosis

FDA registration
HUNTEX CORPORATION·1 product·🇹🇼 Taiwan

Traction Pelvic Belt

FDA registration
HUNTEX CORPORATION·1 product·🇹🇼 Taiwan

Knee Brace

FDA registration
HUNTEX CORPORATION·1 product·🇹🇼 Taiwan

Limb Brace

FDA registration
HUNTEX CORPORATION·1 product·🇹🇼 Taiwan