DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE-MB REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE (CK) TEST ITEM #65411

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CK-MB ASSAY, CATALOGUE NUMBER 317-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool,

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS

Mizra Medical ltd

Manufacturer

🇮🇱 Israel·1 Importer

NA

FDA UDI

PAJUNK MEDICAL SYSTEMS, LP·00858965006793·Continuous Epidural Tray 18G x 2" (50mm)

CUSTOM HEALTHCARE SYSTEMS, INC

FDA UDI

Manus Medical, LLC·00811870034480·

NA

FDA UDI

PAJUNK MEDICAL SYSTEMS, LP·00858965006724·Support Tray (CUSTOM SUPPORT TRAY w/ 2 CHLORAPREP)

CUSTOM HEALTHCARE SYSTEMS, INC

FDA UDI

Manus Medical, LLC·00811870033285·

Custom Healthcare Systems Inc.

FDA UDI

Manus Medical, LLC·00811870034589·

NA

FDA UDI

PAJUNK MEDICAL SYSTEMS, LP·00858965006687·E-Cath Tray 18G x 2'' (51mm) indwelling cathete...

Custom Healthcare Systems, Inc.

FDA UDI

Manus Medical, LLC·00811870036194·

NA

FDA UDI

PAJUNK MEDICAL SYSTEMS, LP·00858965006557·Custom E-Cath Tray 18G x 2'' (51mm) indwelling ...

NA

FDA UDI

PAJUNK MEDICAL SYSTEMS, LP·00858965006656·E-Cath Tray 18G x 4'' (100mm) indwelling cathet...