2,427 results · 39ms · Sources: EU EUDAMED, US FDA

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER

Unimed

FDA registration
UNIMED MEDICAL SUPPLIES INC·1 product·🇨🇳 China

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

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

FB Dermatology S.r.l.

Importer
🇮🇹 Italy

IT328004

Certificate
MDR QMS·FB VISION S.p.A.·BUREAU VERITAS ITALIA S.P.A.

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval
FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·NEUGRAFT

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

Igg (Fab Fragment Specific), Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Igg (Fab Fragment Specific), Antigen, Antiserum, Control

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

db-die Beraterapotheke B.V.

Importer
🇳🇱 Netherlands·1 Manufacturer

CALXYL® SUSPENSION

Basic UDI-DI
EU MDR · Eu Md Class 2a ·OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN HBSAG CONFIRMATORY TEST

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·PearlMatrix™ Bone Graft

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

EC Certification Service GmbH

Importer
🇦🇹 Austria·7 Manufacturers