CALIBRATION VERIFICATION ASSESSMENT (CVA)

FDA 510(k)

FDA Class 2 ·Hematology

PATIENT DATA SYSTEMS CVA

FDA 510(k)

FDA Class 2 ·Anesthesiology

AVA (Augmented Vascular Analysis)

FDA 510(k)

FDA Class 2 ·Radiology

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE MVP VVCS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Vascade MVP VVCS

Cook Incorporated

FDA registration

Cook Incorporated·1 product·🇺🇸 United States

BOSTON SCIENTIFIC CORPORATION

FDA registration

BOSTON SCIENTIFIC CORPORATION·1 product·🇨🇷 Costa Rica

Viceroy Inflation Device

FDA registration

Terumo BCT STERILIZATION SERVICES, Inc.·1 product·🇺🇸 United States

Dilation- Inflation devices/Syringes

FDA registration

PLATINUM FOCUS GROUP LTD.·1 product·🇬🇧 United Kingdom

Syringe Balloon,Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Kit

FDA registration

AvailMed S.A.De C.V.·1 product·🇲🇽 Mexico

Monarch AP

FDA registration

Terumo BCT STERILIZATION SERVICES, Inc.·1 product·🇺🇸 United States

Intellisystem Color Monitor

FDA registration

MERIT MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

Presto Inflation Device

FDA registration

FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD.·1 product·🇨🇳 China

Intellisystem Color Monitor

FDA registration

Merit Medical UK Limited·1 product·🇬🇧 United Kingdom

20/30 Indeflator

FDA registration

Abbott Vascular Netherlands·1 product·🇳🇱 Netherlands

Viceroy Inflation Device

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Summit

FDA registration

COOPERSURGICAL, INC.·1 product·🇺🇸 United States

BOSTON SCIENTIFIC CORPORATION

FDA registration

BOSTON SCIENTIFIC CORPORATION·1 product·🇺🇸 United States

Atrion1619 (SP) - QL Locking Syringe

FDA registration

ISOMEDIX OPERATIONS INC.·1 product·🇺🇸 United States

INDEFLATOR, 20/20, Inflation Device; PPAK 20/20

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States