222 results · 27ms · Sources: EU EUDAMED, US FDA

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

FDA 510(k)
FDA Class 2 ·Anesthesiology

Opera Lebody (Gold), Opera Lebody (Zafiro)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

UGFT3; FHT7

FDA 510(k)
FDA Class 2 ·General Hospital

NON-INVASIVE INFRARED (NIR)

FDA 510(k)
FDA Class 2 ·General Hospital

Temple Touch Pro (TTP) Non-invasive temperature monitoring system

FDA 510(k)
FDA Class 2 ·General Hospital

SIRIO H3

FDA 510(k)
FDA Class 2 ·Radiology

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

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