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