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

InstaStrip OneStep Opiates/Heroine

FDA registration
Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

QUIKSTRIP ONE STEP OPIATES TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Enzyme Immunoassay, Opiates

FDA classification
FDA Class 2 ·Enzyme Immunoassay, Opiates

UltraScore Focused Force PTA Balloon

FDA registration
C.R. BARD, INC.·1 product·🇺🇸 United States

UltraScore Focused Force PTA Balloon

FDA registration
C.R. BARD, INC.·1 product·🇺🇸 United States

UltraScore Focused Force PTA Balloon

FDA registration
C.R. BARD, INC.·1 product·🇺🇸 United States

RM3 Renal Preservation Machine

FDA registration
WATERS MEDICAL SYSTEMS, LLC·1 product·🇺🇸 United States

UltraScore Focused Force PTA Balloon

FDA registration
BARD PERIPHERAL VASCULAR, INC.·1 product·🇺🇸 United States

QuickScreen

FDA registration
PHAMATECH INC.·1 product·🇺🇸 United States

Sensititre GPID Identification, Non Fastidious, GramPositive

FDA registration
TREK DIAGNOSTIC SYSTEMS, LTD.·1 product·🇬🇧 United Kingdom

i-STAT ACT Test

FDA registration
ABBOTT POINT OF CARE CANADA LIMITED·1 product·🇨🇦 Canada

ULTRASCORE Focused Force PTA Balloon

FDA 510(k)
FDA Class 2 ·Cardiovascular

COUNTER UNIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

Catheter, Percutaneous, Cutting/Scoring

FDA classification
FDA Class 2 ·Catheter, Percutaneous, Cutting/Scoring

Spirometer, Therapeutic (Incentive)

FDA classification
FDA Class 2 ·Spirometer, Therapeutic (Incentive)