TOMi Scope

FDA 510(k)

FDA Class 2 ·Radiology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

Device System, Imaging, Tympanic Membrane And Middle Ear

FDA classification

FDA Class 2 ·Device System, Imaging, Tympanic Membrane And Middle Ear

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SUREFIX INTERSPINOUS FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI

FDA 510(k)

FDA Class 2 ·Radiology

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA Heroin Metabolite (6-AM) assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICRO-STRIP FOR OPIATE METABOLITES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI Fentanyl II Enzyme Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COAT-A-COUNT(TM) FENTANYL (TKFN1)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RANDOX OPIATES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology