Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE

Morgan™ HLA SSP DRB Typing Kit, 4 tests/tray (20 tests)

Device

EU IVDD · Eu Ivd Annex 2 List B ·TBG Biotechnology Corp.·On the market·3 countries

VESALIUS STERILE single-use DRB pediatric turb bi-probe

FDA UDI

TELEA ELECTRONIC ENGEENERING SRL·08034055295236·

Morgan™ HLA SSP DRB/DQB Typing Kit, 3 tests/tray (30 tests)

Device

EU IVDD · Eu Ivd Annex 2 List B ·TBG Biotechnology Corp.·On the market·3 countries

Liberator Beacon Tip Locking Stylet

FDA 510(k)

FDA Class 2 ·Cardiovascular

LLD EZ

FDA 510(k)

FDA Class 2 ·Cardiovascular

STIFF STYLETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTRANETICS LLD CS, MODEL 518-039

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEAD STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254

FDA 510(k)

FDA Class 2 ·Cardiovascular

Biotronik Stylets

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIXATION STYLETS, MODELS 335-287 AND 335-288

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSTYLET MODELS EC0010, EC0020

FDA 510(k)

FDA Class 2 ·Cardiovascular

TFX MEDICAL STYLET CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLACER MODEL 6232 STEERABLE STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

STEERABLE STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STYLET KIT, MODELS 6254,6282,6293

FDA 510(k)

FDA Class 2 ·Cardiovascular