1,333 results · 41ms · Sources: EU EUDAMED, US FDA

Sol-Guard TB Safety Syringe

FDA registration
Sol-Millennium Canada, INC.·1 product·🇨🇦 Canada

SOL-GUARD™ Safety Pull-Button Blood Collection Set

FDA registration
Sol-Millennium Canada, INC.·2 products·🇨🇦 Canada

Sol-Care 1, 3, 5, 10 and 20 ml Retractable Safety Syringes

FDA registration
Sol-Millennium Canada, INC.·1 product·🇨🇦 Canada

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM

Fusion

FDA UDI
COOK INCORPORATED·00827002482777·Fusion Lithotripsy Extraction Basket

Fusion

FDA UDI
COOK INCORPORATED·00827002482784·Fusion Lithotripsy Extraction Basket

THERMUFF BAG

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

CARE IV BURN PAD, CATALOG #'S BP2334,BP3472

FDA 510(k)

DURATECH HOSPITAL TOWEL

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

LX2 2.3 Control Unit

FDA UDI
THOR PHOTOMEDICINE LIMITED·05060494130336·S1022 LX2 2.3 Control Unit

LX2 M Control Unit

FDA UDI
THOR PHOTOMEDICINE LIMITED·05060494130329·S1021 LX2 M Control Unit

OTOGRAM, CA3350

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM

DTX-200 BONE DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

Exablate Prostate System

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

HEARING AID (IN-THE-CANAL)

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

HEARING AID (IN-THE-EAR)

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

SMART WAVE GS100

FDA 510(k)
FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology