10,000 results · 41ms · Sources: EU EUDAMED, US FDA

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EDEN Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

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

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

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

FDA Pre-Market Approval
FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP

EDEN ControlCath

FDA registration
JMT CO., LTD.·1 product·🇰🇷 South Korea

EDEN Spinal Fixation System

FDA registration
JMT CO., LTD.·1 product·🇰🇷 South Korea

XTHERMA

FDA registration
TENTECH INC.·1 product·🇰🇷 South Korea

EDEN Spinal Fixation MIS System

FDA registration
JMT CO., LTD.·1 product·🇰🇷 South Korea

10PL

FDA registration
TENTECH INC.·1 product·🇰🇷 South Korea

EDEN Peek Cage

FDA registration
JMT CO., LTD.·2 products·🇰🇷 South Korea

U fit Dental Implant System

FDA registration
T. STRONG INC.·2 products·🇰🇷 South Korea

SG LANSET I, SG LANCETS, SOFT LANCETS, Sure Comfort Lancet

FDA registration
SEWON MEDICAL CO.·1 product·🇰🇷 South Korea

Osteo Cement Needle

FDA registration
JMT CO., LTD.·1 product·🇰🇷 South Korea

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2