INTELLIVUE PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

HP ORVUE INTRA-OP (M2510A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTELLIVUE PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

C7568-CTL, Pointe CRP(HS) Wide Range Controls

FDA registration

HORIBA INSTRUMENTS INCORPORATED·2 products·🇺🇸 United States

Analyzer

FDA registration

Diamond Diagnostics Inc.·2 products·🇭🇺 Hungary

ABX PENTRA CRP CP

FDA registration

HORIBA ABX SAS·2 products·🇫🇷 France

VITROS Calibrator Kit 7

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

C-Reactive Protein (HS)

FDA registration

SANZAY CORPORATION -·2 products·🇺🇸 United States

VITROS Calibrator Kit 7

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS Calibrator Kit 7

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

CRP HS

FDA registration

JAS Diagnostics/Drew Scientific·2 products·🇺🇸 United States

C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

FDA registration

Carolina Liquid Chemistries Corp.·2 products·🇺🇸 United States

VITROS Calibrator Kit 7

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

CRP HIGH SENSITIVITY TEST SYSTEM

FDA registration

CLINIQA CORPORATION·2 products·🇺🇸 United States

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T