3,572 results · 40ms · Sources: EU EUDAMED, US FDA

Skafit anitbacteriële zilververbandmiddelen

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Ska-Fit Medical B.V.·107 devices

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Fia Biomed GmbH

Importer
🇩🇪 Germany·1 Manufacturer

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

ASAHI ZenyteEX PTCA GUIDING CATHETER

Basic UDI-DI
EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·1 device

MICRO SCISSIORS JACOBSON VANNAS BLADE° 160MM -6¼"

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Daddy D Pro·1 device

SBL-2

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Lenstec (Barbados) Inc.·1 device

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval
FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

TC-Matrix Chemistry Analyzer

FDA registration
TECO DIAGNOSTICS·6 products·🇺🇸 United States

200234 QS/NB

Certificate
MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·4 Basic UDI-DIs