222 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
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