2,217 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Back Tape
Device
EU MDR
·
Eu Md Class 1
·NG-International & Co. k.s.·On the market
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
FDA 510(k)
FDA Class 1
·Microbiology
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
FDA 510(k)
FDA Class 2
·Microbiology
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
FDA 510(k)
FDA Class 2
·Microbiology
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Durata, Optisure
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·Microny family of Pacemakers
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Tendril STS, UltiPace
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Assurity, Assurity+, Endurity, Accent family of Pacemakers
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System
Lens, spectacle, non-custom (prescription)
FDA registration
PT. ASTRON LENSINDO NUSA·1 product·🇮🇩 Indonesia
SlideLens
FDA registration
EYEJUSTERS LTD·1 product·🇬🇧 United Kingdom
Lens, spectacle
FDA registration
WENZHOU QIAONEI GLASSES CO., LTD·1 product·🇨🇳 China
KELFRED OPTICAL LTD.
FDA registration
KELFRED OPTICAL LTD.·1 product·🇭🇰 Hong Kong
Spectacle Lens
FDA registration
WENZHOU YOUGE EYEWEAR CO., LTD·1 product·🇨🇳 China
lens, spectacle, non-custom (prescription)
FDA registration
J&Y SAFETY (M) SDN. BHD.·1 product·🇲🇾 Malaysia
PILOT OPTICS INTERNATIONAL CORP. LTD. WENZHOU
FDA registration
PILOT OPTICS INTERNATIONAL CORP. LTD. WENZHOU·1 product·🇨🇳 China