Synermed®

FDA UDI

INFRARED LABORATORY SYSTEMS LLC·05060500092030·Multi-Analyte DAU Control Kit 4 X 15 mL

Azure

FDA UDI

TERRATS MEDICAL SL.·08435457297499·Conic ANYR

Azure

FDA UDI

TERRATS MEDICAL SL.·08435457286455·Conic IC

Synermed®

FDA UDI

INFRARED LABORATORY SYSTEMS LLC·05060500092023·Multi-Analyte DAU Calibrator Kit 4 X 15 mL

CLINI-DENT

FDA 510(k)

FDA Class 1 ·Dental

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

SMYLON (DENTAL STAIN ERASER)

FDA 510(k)

FDA Class 1 ·Dental

FDA Pre-Market Approval

VIGOR(R) DR/SR PACEMAKER SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM

CEDIA DAU MULTI-LEVEL THC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICRO DAU COCAINE METABOLITE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU MULTI-LEVEL THC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) PRX (TM) II AICD SYSTEM

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED

FDA 510(k)

FDA Class 1 ·General Hospital