41 results · 25ms · Sources: EU EUDAMED, US FDA

DBEST OPIATES TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

FDA 510(k)
FDA Class 2 ·General Hospital

DBEST OCCULT BLOOD TEST KIT

FDA 510(k)
FDA Class 2 ·Hematology

AMICAS VISION SERIES PACS, MODEL 4.3

FDA 510(k)
FDA Class 2 ·Radiology

DBEST COCAINE TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DBSET MULTIDRUG SCREEN TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID

FDA 510(k)
FDA Class 2 ·Physical Medicine

AMICAS PACS, VERSION 6.0

FDA 510(k)
FDA Class 2 ·Radiology

KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)

FDA 510(k)
FDA Class 2 ·Radiology

DBEST TETRAHYDROCANNABINOL TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DBEST HCG PANEL TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ST-302 INFRAREX

FDA 510(k)
FDA Class 2 ·Physical Medicine

SD-956 ULTRASOUND THERAPY

FDA 510(k)
FDA Class 2 ·Physical Medicine

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

FDA 510(k)
FDA Class 2 ·Physical Medicine

SD-100 SKYEAR THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital