10,000 results · 72ms · Sources: EU EUDAMED, US FDA

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

CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

FDA 510(k)
FDA Class 2 ·Ophthalmic

AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

PTS PANELS HDL CHOLESTEROL TEST STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CRONUS GUIDEWIRE, MODEL 001-001470-1

FDA 510(k)
FDA Class 2 ·Cardiovascular

Lauf gr/gr/weiß/weiß Nub gel/Nub/Nylo/Ri.nap W

Device
EU MDR · Eu Md Class 1 ·Thanner GmbH·On the market

330-00-020 ARSENAL DRILL TOWER 2.7/3.5/4mm OUTER SLEEVE

FDA registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD·4 products·🇲🇾 Malaysia

330-00-020 ARSENAL DRILL TOWER 2.7/3.5/4mm OUTER SLEEVE

FDA registration
Straits Orthopaedics (MFG) Sdn Bhd·4 products·🇲🇾 Malaysia

330-00-020 ARSENAL DRILL TOWER 2.7/3.5/4mm OUTER SLEEVE

FDA registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD·4 products·🇲🇾 Malaysia

Arsenal Ankle Plating System

FDA registration
Trilliant Surgical LLC·4 products·🇺🇸 United States