63 results · 20ms · Sources: EU EUDAMED, US FDA

DBEST AMPHETAMINES TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CARBON DIOXIDE (C02)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

URINE REAGENT STRIP-3 PARAMETERS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DBEST REAGENT STRIP FOR URINALYSIS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DBEST HCG 2 IU/ML TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DBEST ONE STEP OCCULT BLOOD TEST KITS

FDA 510(k)
FDA Class 2 ·Hematology

MEDLOG, MODEL 1-0-10

FDA 510(k)
FDA Class 2 ·Cardiovascular

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F

FDA 510(k)
FDA Class 2 ·Cardiovascular

Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways

FDA 510(k)
FDA Class 2 ·Radiology

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

SD-730 IF-SDS, PERFECT PULSE IF-SDS

FDA 510(k)
FDA Class 2 ·Neurology

CONDUCTIVE GEL FOR ULTRASOUND

FDA 510(k)
FDA Class 2 ·Neurology

CSF/URINE TOTAL PROTEIN

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)
FDA Class 2 ·Neurology

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST

FDA 510(k)
FDA Class 2 ·Immunology

IF-727 INTERFERENTIAL STIMULATOR

FDA 510(k)
FDA Class 2 ·Neurology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

FDA 510(k)
FDA Class 2 ·Cardiovascular