LOOP RECORDER VITAPHONE, 3100 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATIENT ALERT MODEL 555

FDA 510(k)

FDA Class 2 ·Cardiovascular

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

FDA 510(k)

FDA Class 2 ·Cardiovascular

PER, MODEL MEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Straumann® Retentive System – Novaloc TiN Abutments

FDA 510(k)

FDA Class 2 ·Dental

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR, MODELS ND04, ND05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

NEUROLAC NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

C. difficile GDH Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

C.difficile GDH Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device