GrayDuck Stent

FDA 510(k)

FDA Class 2 ·Radiology

QBioScan

FDA 510(k)

FDA Class 2 ·Neurology

XSTAT 30, 1-Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XSTAT 30, 3-PACK, XSTAT 30, 1-PACK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TZ SKULL PIN Adult

FDA 510(k)

FDA Class 2 ·Neurology

XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XSTAT 30 Pouch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RDK Rare Disease Knowledge

Basic UDI-DI

EU MDR · Eu Md Class 1 ·as we know·1 device

OMARE, SL

Importer

🇪🇸 Spain·3 Manufacturers

BSW Ipari, Kereskedelmi és Szolgáltató Kft.

Importer

🇭🇺 Hungary·1 Manufacturer

Test, Follicle Stimulating Hormone (Fsh), Over The Counter

FDA classification

FDA Class 1 ·Test, Follicle Stimulating Hormone (Fsh), Over The Counter

Prosthesis, Esophageal

FDA classification

FDA Class 2 ·Prosthesis, Esophageal

Bag, Polymeric Mesh, Pacemaker

FDA classification

FDA Class 1 ·Bag, Polymeric Mesh, Pacemaker

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FOLATE ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CapnoSpot™ Pneumothorax Decompression Indicator

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VIGIL HEMOGLOBIN (HBALC) CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry